<?xml version="1.0" encoding="utf-8"?>
<source><publisher>St Jude Medical Jobs</publisher><publisherurl>http://jobs.sjm.com</publisherurl><lastBuildDate>2012-05-24 01:51:56.301567</lastBuildDate><job><country_short>USA</country_short><city>Plymouth</city><description>Analyst, IT Business
Job Requisition #: 13365
Date Posted: 05/22/2012
Category: Information Technology
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Position Summary:
Provides leadership and direction to and works with business customers in identifying and fulfilling their informational needs. Functions as a project leader for system analysis, design, development and implementation assignments.


Essential Functions:
Provides application development support and coordination primarily to the Manufacturing
and Distribution organizations by:
• Facilitating meetings in the business area to review business processes and identify
information system requirements and/or needs.
• Making appropriate recommendations for continuing, modifying, or abandoning
proposed projects and/or systems based on the results of feasibility studies and/or
cost/benefit analyses.
• Maintaining and documenting the logical and physical data models including data flow diagrams.
• Developing business process flows and data models required by the department methodology for new system development or for process redesign.
• Preparing project and system documentation consistent with standards and
procedures outlined in the development methodologies.
Provides project management support as a leader or member of a project team:
• Develops project plans, work breakdown structures and task dependencies,
communication plans, etc., according to the development methodologies.
• Manages project activities and motivates members of the project team.
• Provides updates and thorough communication to the project team, information
systems and the impacted business areas.
• Coordinates the implementation of information systems with IS personnel and
members of the impacted business areas.
Provides coaching and training support:
• Maintains proficiency in the tool sets used within the supported business areas.
• Supports the business areas in their tool sets, including training and developing
subject matter experts within the supported business areas.
• Conducts training that quickly prepares participants to use a maximum of system
features.
Maintains relationships and communications with business and IS units:
• Keeps informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals.
• Understands the various business entities, their information systems developed by IS, and
the applications that they developed on their own.
• Serves as a liaison between IS and the supported business areas.
• Communicates effectively with management to enhance their understanding of the
opportunities and limitations of information systems.
• Provides effective written and verbal communications.

Qualifications:
• This person must have excellent communication and customer service skills and strong
leadership and team motivation skills in order to manage work that requires effective
delivery to internal SJM customers.
• This includes bridging communication between technical areas and business areas
for a full and complete understanding of expectations.
• Five to seven years business analyst experience or equivalent gained through a combination of formal training and progressive work experience, including project management experience.
• Bachelor’s degree in Business, Computer Science or related field is preferred.
• MBA a plus.



|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-05-22 19:30:31</date_new><country>United States</country><company>St. Jude Medical</company><title>Analyst, IT Business</title><state>Minnesota</state><reqid>13365</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28867994</uid><url>http://jobs.sjm.com/xml/28867994/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Clinical Programs Manager
Job Requisition #: 13203
Date Posted: 05/22/2012
Category: Clinical
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Job Overview
The Clinical Programs Manager will manage the successful completion of all clinical programs. Will also be responsible for developing program budgets and hitting both enrollment and spending targets. Staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. Manage the timely development of PMA and other regulatory submissions.

Responsibilities:
• Manage the successful and timely execution of all device clinical trials
• Responsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations
• Responsible for the training, initiation and management of clinical trial sites
• Establish and manage trial budgets including enrollment targets
• Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending
• Participate in the design and development of new trials
• Responsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis
• Develop and maintain individual training programs for all staff
• Able to assist in the drafting and development of publications based on the results of the clinical trials
• Develop and maintain strong relationships with principal investigators at clinical trial sites
• Ensure that St. Jude Medical is using the most current tools in the management of clinical trials
• Travel estimated at 30%

Requirements:
• BA/BS in life sciences or nursing
• 10+ years experience in clinical research
• 5+ years experience successfully managing a team of clinical research professionals
• 3-5 years clinical research experience in medical device PREFERABLY
• Demonstrated knowledge of and experience with GCP and all US regulations
• Hands on experience in IDE clinical trials and the preparation of PMAs
• Comfortable in both the clinical and business setting
• Comfortable presenting to senior management
• Ability to work independently and take direction from others
• Strong work ethic
• Excellent communication, problem-solving and organizational skills
• Computer proficiency including Microsoft Office applications

Preferred Qualifications:
• Advanced degree in life sciences or nursing a strong plus
• Knowledge and experience with European and Japan device clinical trials a strong plus
• Experience in the cardiovascular therapeutic areas



|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-05-22 19:30:08</date_new><country>United States</country><company>St. Jude Medical</company><title>Clinical Programs Manager</title><state>Minnesota</state><reqid>13203</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28867984</uid><url>http://jobs.sjm.com/xml/28867984/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Engineer - Process Development
Job Requisition #: 13302
Date Posted: 05/21/2012
Category: Process Development Engineering
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Position Description:
A Process Engineer will provide Lean and Six Sigma manufacturing solutions and new manufacturing process technologies. Primary focus area will be new product development and supporting manufacturing as required.

Focus on improving existing production lines as well as assist the transfer of new process into manufacturing utilizing lean methodologies. Utilize Process Failure Mode Effects Analysis (PFMEA) and statistical methods to analyze manufacturing processes for new product development and process optimization. Author new or revise existing engineering documentation such as manufacturing processes, inspection processes, materials specifications and drawings as required. Work closely with production to ensure that manufacturing goals are met. Author and execute IQ, OQ and PQ protocols. Author equipment specifications and write justifications for capital expenditures. Ensure good documentation practice is followed to meet quality system requirements.

Education:
Bachelor Degree in Engineering or Materials required.

Experience/Skills:
1-5 years experience in process engineering/development of regulated products (medical devices preferred).
Working knowledge of basic PC programs (Word, Excel, Power Point, VISIO, Access etc.).
Working knowledge of Design for Manufacture (DFM), FMEA, Process Validation, Project Management, Lean methodologies, DOE, SPC and Gage R&amp;R preferred.
Excellent data analysis and reporting skills.
Excellent patience and communication skills.
Experience with stainless steel and/or nitinol wire braiding preferred.
Experience with nitinol material processing preferred.
Experience with tool design and automation preferred.


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-05-21 20:24:32</date_new><country>United States</country><company>St. Jude Medical</company><title>Engineer - Process Development</title><state>Minnesota</state><reqid>13302</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28837099</uid><url>http://jobs.sjm.com/xml/28837099/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Engineer - Process Development
Job Requisition #: 13243
Date Posted: 05/16/2012
Category: Process Development Engineering
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Position Description:
A Process Engineer will provide Lean and Six Sigma manufacturing solutions and new manufacturing process technologies. Primary focus area will be new product development and supporting manufacturing as required.
Autonomy: Individual contributor with a moderate to high level of day-to-day work direction from their supervisor.
Work Content: Typical projects will be focused towards individual process technologies affecting one to many products. Process Engineers will usually be members of a larger project team.

Job Accountabilities:
Process Development /Operations:
Focus on improving existing production lines as well as assist the transfer of new process into manufacturing utilizing lean methodologies. Utilize Process Failure Mode Effects Analysis (PFMEA) and statistical methods to analyze manufacturing processes for new product development and process optimization. Author new or revise existing engineering documentation such as manufacturing processes, inspection processes, materials specifications and drawings as required.Work closely with production to ensure that manufacturing goals are met. Author and execute IQ, OQ and PQ protocols. Author equipment specifications and write justifications for capital expenditures. Ensure good documentation practice is followed to meet quality system requirements.

Supplier Responsibilities:
May interface with component suppliers to resolve manufacturing and quality issues.

Teamwork/Leadership:
Work effectively in a cross-functional team environment as an extended team member.
May provide work direction to technicians.
May train manufacturing personnel.May be a core team member for a small project.

Education:
Bachelor Degree in Engineering or Materials required.

Experience/Skills:
1-5 years experience in process engineering/development of regulated products (medical devices preferred).
Working knowledge of basic PC programs (Word, Excel, Power Point, VISIO, Access etc.).
Working knowledge of Design for Manufacture (DFM), FMEA, Process Validation, Project Management, Lean methodologies, DOE, SPC and Gage R&amp;R preferred.
Excellent data analysis and reporting skills.
Excellent patience and communication skills.
Experience with nitinol preferred.
Experience with tool design, injection molding, packaging, polymer joining/reflow, heat setting, and automation preferred.


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-05-16 19:42:14</date_new><country>United States</country><company>St. Jude Medical</company><title>Engineer - Process Development</title><state>Minnesota</state><reqid>13243</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28738978</uid><url>http://jobs.sjm.com/xml/28738978/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Intern, R&amp;D (Summer &amp; Fall Semesters)
Job Requisition #: 13031
Date Posted: 05/01/2012
Category: Internship
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Summary:
As a R&amp;D Intern, you will provide technical engineering to support product development and transfer of innovative, minimally invasive medical products. You will work individually or with a group of engineers on the design, development, testing and documentation following in-place design control procedures. In this role you will generate the necessary documentation to convey design intent, including drawings, materials specifications, and test data to support regulatory submission of these devices.

Duties and Responsibilities:
• Construction and evaluation of prototype medical devices
• Writing protocol and reports
• Perform design verification and validations testing
• Develop tooling and fixturing for testing
• Generate/ECO engineering documentation, including drawings, materials specifications, manufacturing procedures, BOM's, inspection procedures.

Qualifications:
• Current student pursuing a Mechanical or Biomedical Engineering degree, or other related engineering degree – Must be enrolled in the 2012 fall semester
• Strong communication, record keeping and problem solving skills.
• Demonstrated creativity and "hands on" prototyping skills - ability to prototype devices that have been conceptualized.
• Working knowledge of ISO, GMP and QSR; FDA experience a plus.
• Computer proficiency with Microsoft applications.
• Ability to interact with a range of personalities.
• Ability to take initiative and work independently

Assignment: Full-timeSummer, continuing Part-time Fall Semester
Please Note: No housing, transportation or relocation allowance provided


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-05-09 18:01:42</date_new><country>United States</country><company>St. Jude Medical</company><title>Intern, R&amp;D (Summer &amp; Fall Semesters)</title><state>Minnesota</state><reqid>13031</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28574456</uid><url>http://jobs.sjm.com/xml/28574456/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Engineer - Research &amp; Development
Job Requisition #: 13134
Date Posted: 05/08/2012
Category: Engineering
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Position Summary
We are seeking a high caliber, experienced, hands-on Senior Product Development Engineer that is innovative in driving new product development for our Minnesota based Cardiovascular division team. This is a high profile position that will work with a team of engineers to develop and commercialize new medical devices and delivery systems.

Duties and Responsibilities:
• Generates novel design ideas, builds prototypes,develops and refines design concepts
• Generates test data and performs analysis to make design decisions
• Works with suppliers and customers
• Develops design specifications based on customer feedback and intended clinical use
• Develops and refines test methods and models
• Plans and executes design characterization, verification, and validation builds and testing
• Generates and manages design documentation

Technologies:
•Biocompatible material selection for delivery systems and implants
•Bioprosthetic implants
•Mechanical design of biocompatible metals and plastics
•Machining
•Molding
•Nitonol
•Extrusion
•Thermoforming
•Packaging and Sterilization

Qualifications:
• Bachelor's degree in Mechanical or Biomedical Engineering
• 5+ years of product development (R&amp;D) experience
• 5+ years of medical device development experience
• Endovascular device and delivery system design experience
• Experience with statistical data analysis and design of experiments
• CAD design and drafting experience
• Proven leader in a cross functional environment
• Polished communicator
• Excellent documentation writing skills; clear and concise using objective evidence and language
• Excellent reputation for building relationships
• Organized, on-time, and detailed project management skills
• Energized attitude




|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-05-08 18:57:29</date_new><country>United States</country><company>St. Jude Medical</company><title>Engineer - Research &amp; Development</title><state>Minnesota</state><reqid>13134</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28541769</uid><url>http://jobs.sjm.com/xml/28541769/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Technician - Desktop Support
Job Requisition #: 13135
Date Posted: 05/08/2012
Category: Information Technology
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Position Summary:
The Desktop Support Technician I role operates as a first level of IT support within the Cardiovascular IT organization. This position focuses primarily on the level 1 support aspects of PC hardware, software and end user issues. This role will regularly interacts with both technical and business individuals, and has frequent direct contact with all levels of business users, ranging from manufacturing employees to executives. A professional appearance, service oriented demeanor, and good customer service skills are required. Overall work direction is given from the desktop support supervisor as well as the IT manager, however day to day guidance is also provided by the level II and senior desktop positions. The ability to escalate more involved technical issues to higher level technicians is important.

Essential Functions:
• Physical installation of PC's and related peripherals.
• Perform warranty replacement on PC hardware.
• Work with client images for deployment of operating systems to desktops.
• Participate in deployment and support of applications, software, end user hardware in accordance with technology standards.
• Provide level 1 support of both hardware and software issues.
• Manage service requests using the incident management application.
• Maintain documentation on procedures as required.
• Support LAN connectivity from the workstation to the network switch for all client end points.

Other Duties:
• Participate as a project resource as necessary.
• Assist in testing of updates within defined change control processes.
• Effectively prioritize and execute tasks as directed by the desktop support supervisor.
• Participate in cross divisional IT efforts as deemed necessary.

Qualifications:
• 1-3 years related IT support experience, or 2 - 4 year degree in related IT field desired.
• Microsoft Certified Technical Specialist (MCTS) or IT Professional (MCTIP) in Microsoft Windows Operating System or Microsoft Office technologies a plus.
• Experience in supporting manufacturing and clean room environments also plus.
• Solid technical aptitude and troubleshooting skills.
• Solid understanding of standard PC and related hardware.
• Excellent communication and customer service skills.
• Ability to communicate with both technical and non-technical individuals.


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-05-08 18:57:29</date_new><country>United States</country><company>St. Jude Medical</company><title>Technician - Desktop Support</title><state>Minnesota</state><reqid>13135</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28541771</uid><url>http://jobs.sjm.com/xml/28541771/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Group Lead - Production
Job Requisition #: 13138
Date Posted: 05/07/2012
Category: Production
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
First shift position: (5AM - 2:30PM; M-F)

Position Summary:
Ensures the effective use of material, equipment and personnel in producing quality production; Responsible for ensuring inventory accuracy, cycle counts, and meeting build schedules;

Essential Functions:
• Manages directly the manufacture of medical device;
• Ensures that quality and production goals are met;
• Trains production operators on GMP, MP and retrain as needed;
• Daily meeting with manufacturing operators for better communication and continuous improvement;
• Organizes work schedule, Monitors performance and reports status;
• Ensures PM (preventive maintenance) and Calibration stickers are up to date;
• 5S audit and weekly meeting with other area value stream group-leads in a organization; and more;

Qualifications:
• Prefer two years of college or equivalent.
• Prefer three - five years experience as a group-lead in a manufacturing environment.
• Must be detail oriented, self-motivated, and have good communication skills. Must have the ability to read and interpret written documentation. Desired demonstrated knowledge of LEAN manufacturing, assembly, and production technical skills, and quality practices;
• Computer skills desired in excel Microsoft word and have trained SAP (S2S) software
• Ability to effectively work and communicate with others is critical.
• Prefer pervious training experience in a manufacturing environment.
• Six Sigma Green Belt Training



|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-05-07 18:23:12</date_new><country>United States</country><company>St. Jude Medical</company><title>Group Lead - Production</title><state>Minnesota</state><reqid>13138</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28478543</uid><url>http://jobs.sjm.com/xml/28478543/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Senior Clinical Research Coordinator
Job Requisition #: 13159
Date Posted: 05/04/2012
Category: Clinical
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Senior Clinical Research Coordinator will implement and carry out functions of clinical research.

Responsibilities:
• Follow department Standard Operating Procedures
• Assist with pre study evaluations
• Initiate clinical investigations by arranging proctoring and staff training
• In-house case report form auditing and data verification
• Assist with regulatory reports (annual reports, progress reports)
• Work independently on specific study projects
• Assist CRA in setting up sites (IRB approvals, Investigator agreements, and study start up)
• Assist with monitoring visits
• Interact with study sites
- Generate follow up reminder reports and send to investigators on a regular basis
• Acquire professional, product and market expertise via independent reading, networking and training
• Resource/train other clinical research coordinators
• Travel approximately 10%
• Participate in professional activities outside of normal business hours
• Other duties as requested

Requirements:
One of the following:
• High School Diploma with 4 years experience in an administrative role OR
• BA/BS in Medical Science or Nursing or equivalent
• 3 years experience in clinical research, preferably medical device company
• Computer proficiency required: Word, Excel, Access, PowerPoint, internet, email
• Ability to constructively interact with a range of personalities and positions inside and outside the organization
• Attention to detail
• Ability to organize, prioritize, and manage tasks in a changing environment
• Ability to work independently and take direction from others



|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-05-04 19:20:11</date_new><country>United States</country><company>St. Jude Medical</company><title>Senior Clinical Research Coordinator</title><state>Minnesota</state><reqid>13159</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28440690</uid><url>http://jobs.sjm.com/xml/28440690/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Senior IT Business Analyst
Job Requisition #: 13033
Date Posted: 04/23/2012
Category: Information Technology
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Position Summary: Provides leadership and direction to and works with business customers in identifying and fulfilling their informational needs. Functions as a project leader for system analysis, design, development and implementation assignments.

Essential Functions:
Provides application development support and coordination primarily to the Clinical organization by:
• Facilitating meetings in the business area to review business processes and identify information system requirements and/or needs.
• Making appropriate recommendations for continuing, modifying, or abandoning proposed projects and/or systems based on the results of feasibility studies and/or cost/benefit analyses.
• Maintaining and documenting the logical and physical data models including data flow diagrams.
• Developing business process flows and data models required by the department methodology for new system development or for process redesign.
• Preparing project and system documentation consistent with standards and procedures outlined in the development methodologies.

Provides project management support as a leader or member of a project team:
• Develops project plans, work breakdown structures and task dependencies, communication plans, etc., according to the development methodologies.
• Manages project activities and motivates members of the project team.
• Provides updates and thorough communication to the project team, information systems and the impacted business areas.
• Coordinates the implementation of information systems with IS personnel and members of the impacted business areas.

Provides coaching and training support:
• Maintains proficiency in the tool sets used within the supported business areas.
• Supports the business areas in their tool sets, including training and developing subject matter experts within the supported business areas.
• Conducts training that quickly prepares participants to use a maximum of system features.

Maintains relationships and communications with business and IS units:
• Keeps informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals.
• Understands the various business entities, their information systems developed by IS, and the applications that they developed on their own.
• Serves as a liaison between IS and the supported business areas.
• Communicates effectively with management to enhance their understanding of the opportunities and limitations of information systems.
• Provides effective written and verbal communications.

Qualifications:
• This person must have excellent communication and customer service skills and strong leadership and team motivation skills in order to manage work that requires effective delivery to internal SJM customers.
• This includes bridging communication between technical areas and business areas for a full and complete understanding of expectations.
• Five to seven years business analyst experience or equivalent gained through a combination of formal training and progressive work experience, including project management experience in Clinical or a related function.
• Bachelor's degree in Business, Computer Science or related field is preferred.
• MBA a plus.


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-04-23 20:17:20</date_new><country>United States</country><company>St. Jude Medical</company><title>Senior IT Business Analyst</title><state>Minnesota</state><reqid>13033</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28080404</uid><url>http://jobs.sjm.com/xml/28080404/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Clinical Research Associate
Job Requisition #: 12963
Date Posted: 04/20/2012
Category: Clinical
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Clinical Research Associate will manage and execute assigned clinical studies with guidance. This will include Support professionalism and scientific expertise of department.

Responsibilities:
Manages assigned clinical study centers
Sets up sites: clinical research agreements, site budgets, IRB Approvals, etc
Prepares and maintains case report forms, informed consent and other specialized documents for clinical investigations
Conduct study training or other formal training at site and at the study team level
Assists Regulatory in annual report and progress reports to the FDA
Reviews data forms and DCF generation
Responsible for data review and approval of DCFs
Generates presentations when requested by investigators
Acquires professional, product and market expertise via independent reading, networking and training
Travels approximately 30% but varies according to trial needs
Participates in professional activities outside of normal business hours
Performs other related duties as requested

Requirements:
BA/BS in business, science or nursing
3-5 years experience in clinical research including monitoring
Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization
Excellent written and verbal communication skills
Ability to work independently and take direction from others


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-04-20 18:10:04</date_new><country>United States</country><company>St. Jude Medical</company><title>Clinical Research Associate</title><state>Minnesota</state><reqid>12963</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28034728</uid><url>http://jobs.sjm.com/xml/28034728/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Associate - Clinical Research
Job Requisition #: 12962
Date Posted: 04/20/2012
Category: Clinical
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Clinical Research Associate II position will assist in the planning, designing, and execution of clinical studies under the supervision of the Clinical Manager with focus on compliance to applicable regulatory standards and monitoring of investigational centers.

Responsibilities:
• Assist with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools.
• Initiate site activation documentation
• Participate in site qualification and site initiation process, including scheduling of monitor activities with site personnel.
• Assist in planning and preparing materials for investigator and coordinator meetings.
• Assist in training of investigators and coordinators.
• Track and report progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events.
• Coordinate and conduct monitoring visits at participating centers to ensure compliance to the clinical protocol, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
• Assist in query generation and resolution.
• Assist with core lab data management.
• Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues.
• Write and/or provides input to the monitoring plan
• Provide updates on progress of assigned clinical sites to study management.
• Develop expertise with SOP's, GCP's, and regulatory compliance guidelines.
• Participate in training/orientation or new employees.
• Contribute to ongoing SOP review and development.
• Review site changes to informed consent forms.
• May create and conduct presentations.

Qualifications:
• Four year degree in physical science
• 1-2 years experience monitoring
• Experience directly supporting clinical research or similar experience in a medical/scientific area
• Knowledge of clinical and outcomes research study design
• Working knowledge of GCPs, and regulatory compliance guidelines for clinical trials
• Knowledge of medical terminology
• Able to travel 40% on average
• High attention to detail and accuracy
• Strong written and oral communications skills
• Able to manage multiple tasks
• Good problem-solving skills
• Proficient computer skills (MS Office)
• Current driver's license

Preferred Qualifications:
• Two years applicable health care experience
• Advanced degree



|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-04-20 18:09:59</date_new><country>United States</country><company>St. Jude Medical</company><title>Associate - Clinical Research</title><state>Minnesota</state><reqid>12962</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28034726</uid><url>http://jobs.sjm.com/xml/28034726/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Senior Clinical Safety Specialist
Job Requisition #: 12987
Date Posted: 04/20/2012
Category: Clinical
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Senior Clinical Safety Specialist will work under the direction of the Senior Director, Medical/Scientific Affairs processing adverse events as defined per clinical protocols. This role will also assist with the education of clinical teams on identification and reporting of adverse events specific to clinical research projects.

Responsibilities:
• Process all adverse events per Work Instruction/ Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for full review and reporting
• Collaborate with Safety team members in preparation for DMC/DSMB/CEC meetings
• Oversee weekly review of adverse events with applicable study teams
• Review all adverse events in accordance with the specified Clinical Investigation Plan (CIP)
• Code adverse events where directed by the governing processes
• Draft AE narratives, as required, for inclusion in all FDA report submissions
• Work with clinical study teams to ensure adherence to protocol, regulations and SJM policies regarding the reporting of adverse events
• Maintain knowledge of current FDA, ICH, and ISO regulatory rules and policies affecting CVD Clinical study related products
• Assist with training on study specific adverse event definitions prior to start of clinical study/registry and ongoing as needed to insure compliance and accurate reporting
• Assist with revision or writing of SOP/Instructions/Procedures and changes to support clinical department
• Assist in development of study specific case report forms
• Assist in clinical study protocol development
• Assist with BIMO audits, when directed
• Collaborate on additional Clinical Research activities, as needed
• Other duties as assigned

Requirements:
• Bachelor’s degree in an area of science or RN
• Strong understanding of adverse events and risk assessment
One of the following:
• 2-5 years experience within pharmacovigilance or medical safety
• 5+ years experience in medical device or Pharma in
clinical research or risk assessment

• Working knowledge of medical terminology, clinical research conduct, laws, regulations, and standards
• Proficient in MS Office and database navigation skills
• Strong interpersonal and communication skills
• Excellent record keeping, organizational skills, and problem solving abilities
• Highly motivated and capable of working independently and as a team member
• Experience coordinating, prioritizing, and setting timelines for multiple tasks
• Ability to multi-task and adapt to a rapid pace environment
• Strong technical writing skills

Preferred qualifications:
• 3-5 years of experience in a hospital or clinic setting, preferably within the cardiovascular arena
• PharmD or PhD




|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-04-20 18:09:08</date_new><country>United States</country><company>St. Jude Medical</company><title>Senior Clinical Safety Specialist</title><state>Minnesota</state><reqid>12987</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>28034690</uid><url>http://jobs.sjm.com/xml/28034690/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Clinical Program Budget Manager
Job Requisition #: 12522
Date Posted: 04/12/2012
Category: Finance
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Clinical Program Budget Analyst will develop, analyze, and facilitate the execution of all Cardiovascular Clinical Affairs study budgets. This position will work with all clinical program managers and directors to ensure clinical trial financial forecasts are updated accurately and efficiently and are consistent with organizational objectives.

RESPONSIBILITIES
• Assists the Clinical Program Budget Manager in communicating budget timelines and preparing budgets for review
• Negotiates changes to Clinical Trial site reimbursements and new site reimbursement agreements
• Identifies and resolves budget and negotiation issues to a satisfactory conclusion meeting the needs of both clinical site customer and core business
• Assists on monthly and quarterly direct clinical trial expense reporting, accruals and forecasting
• Compiles negotiated cost history comparing the average, median, high, and lowest costs negotiated for each clinical trial
• Inputs budget data into the company's budget templates and software system
• Provides analysis to Clinical Program Budget Manager on each clinical trial budget and edits to budgets
• Reviews budget data on a monthly and quarterly basis with clinical trial program managers
• Assists Clinical management on budget planning related to Strategic planning
• Works closely with the Finance department to ensure transparency and continuity of AOP budget data and monthly expense analysis
• Follows Clinical operational processes in the preparation of clinical trial budgets
• Ensures accuracy and completeness of the negotiated site reimbursements for the planning and tracking system
• Tracks the negotiated budgets against the AOP plan

REQUIREMENTS:
• Bachelor’s degree in Finance or area of business management
• 2-4 years experience in finance and contract negotiation
• Experience negotiating corporate or customer contracts
• Knowledge of financial tracking software
• Highly proficient in MS Excel
• Experience structuring and performing sophisticated financial projections and analyses
• Experience managing time efficiently and handling multiple tasks
• Ability to assimilate detailed information into the bigger picture
• Excellent written and oral communication skills with small or large group audiences




|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-04-12 20:21:17</date_new><country>United States</country><company>St. Jude Medical</company><title>Clinical Program Budget Manager</title><state>Minnesota</state><reqid>12522</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>27852714</uid><url>http://jobs.sjm.com/xml/27852714/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Medical and Scientific Affairs Director
Job Requisition #: 12819
Date Posted: 04/02/2012
Category: Clinical
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
St. Jude Medical, Inc.
Job Title: Director, Medical and Scientific Affairs

Duties:
Plan, direct, and coordinate medical and scientific activities related to clinical investigation and research.
Determine scientific goals, and develop and implement policies and procedures for clinical scientific research to ensure regulatory and industry requirements.
Oversee a research team engaged in a regulated industry clinical investigation and research, and serve as primary internal resource for medical and scientific guidance across current and future product lines.
Applying highly developed management and leadership skills, manage medical and scientific team with primary purpose to provide in-depth medical and scientific support to company’s cross functional development and execution team; serve as medical resource to create and implement clinical trial strategies and methodologies to obtain market approval; develop and maintain standards of care relevant to industry products and patient population and disease pathologies of interest.
Develop, implement, and oversee internal medical monitoring processes to include
adverse event reporting and safety surveillance procedures.
Provide oversight of independent committees including clinical events committees,
and data safety monitoring procedures to ensure compliance with regulatory
standards and FDS expectations; assist Business Development in strategic
planning and due diligence activities; assist with development of educational
materials, educational programs and participate in such.

Job Requirements:
M.D., or equivalent foreign degree as determined by a written evaluation, with at least six (6) years experience as clinical research scientist working with medical devices related to cardiology and cardiac procedures, including cardiac catherization, percutaneous coronary interventions, and cardiovascular/metabolism therapeutics.
Experience must include designing and conducting multiple randomized, controlled clinical research trials using IND, NDA, IDE, and PMA submissions, and must include pharmamacovigilance with medical safety assessments, medical safety reports, and biocompatibility testing in compliance with CCP, ICH, and US FDA regulations.


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-04-03 03:22:11</date_new><country>United States</country><company>St. Jude Medical</company><title>Medical and Scientific Affairs Director</title><state>Minnesota</state><reqid>12819</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>27603030</uid><url>http://jobs.sjm.com/xml/27603030/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Specialist - Regulatory Affairs
Job Requisition #: 12900
Date Posted: 04/02/2012
Category: Regulatory Affairs
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Regulatory Affairs Specialist ensures products and procedures comply with regulatory agencies specifications.

Responsibilities:
• Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals
• Prepare new product Design Dossiers for submission to Notified Bodies and Health Canada
• Prepare appropriate documentation for renewing CE mark certification
• Prepare appropriate documentation for annual renewals submitted to Health Canada
• Prepare Technical Files for product s with self certified CE Marks
• Update Technical Files on annual basis
• Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations
• Act as a core member on development teams, providing RA guidance, and project regulatory assessments
• Work with Engineering teams (R&amp;D, Quality, Design Assurance) to evaluate testing strategies
• Interface directly with FDA, Notified Bodies and Health Canada
• Communicate and coordinate regulatory activities with other departments
• Review of product and manufacturing changes for compliance with applicable regulations
• Review of protocols and reports to support regulatory submissions
• Support international regulatory submissions (Korea, others)
• Product support for minimally invasive structural heart technologies
• Assist with IDE &amp; PMA applications, amendments and supplements

Qualifications:
• BA or BS in a technical discipline with at least four years technical experience
• One to three years regulatory experience
• Experience with 510(k) applications and US device regulations
• Experience with EU and Canadian medical device regulations and submissions


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-04-03 03:21:52</date_new><country>United States</country><company>St. Jude Medical</company><title>Specialist - Regulatory Affairs</title><state>Minnesota</state><reqid>12900</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>27603020</uid><url>http://jobs.sjm.com/xml/27603020/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Demand Planner
Job Requisition #: 12663
Date Posted: 03/21/2012
Category: Purchasing
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Position Summary:
Responsible for developing and maintaining top level manufacturing build plans, for existing and new products, that meet defined service level and inventory targets for the division

Essential Functions:
• Global Sales &amp; Operations Planning process preparation and facilitation, including interface with Marketing, Sales, Production, Accounting, and other operations groups that are part of this process
• Clearly communicate agreed upon production quantities and mix to Production and other Operations groups.
• Zero back order goal - when back order exists full responsibility for back order management, status, prioritization, communication
• Production Plan attainment reporting and communication, including holding Operations accountable weekly to S&amp;OP agreed upon production plans and notifying Accounting of variances to plan
• Set and maintain appropriate inventory levels that meet service level objectives to customers balanced with divisional DIOH (Days Inventory On Hand) goals.
• Plan new product introductions and phase outs to achieve planned launch dates with targeted inventory levels
• Monthly inventory management of excess, obsolete, expiring inventory, including developing and implementing solutions to minimize inventory write-offs and communication with Finance on write-off potential
• Proficient in ERP system functionality to perform job-including driving S&amp;OP agreed upon plans thru MRP to Production for build plans or Purchasing for raw material planning

Qualifications:
• Bachelor Degree required
• APICS or other Planning related certifications preferred.
• Minimum 3 years experience in Planning function
• Medical Device experience preferred.
• Experience with SAP preferred.



|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-03-22 01:48:21</date_new><country>United States</country><company>St. Jude Medical</company><title>Demand Planner</title><state>Minnesota</state><reqid>12663</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>27314755</uid><url>http://jobs.sjm.com/xml/27314755/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Demand Planner
Job Requisition #: 12664
Date Posted: 03/21/2012
Category: Operations
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
Position Summary:
Responsible for developing and maintaining top level manufacturing build plans, for existing and new products, that meet defined service level and inventory targets for the division

Essential Functions:
• Global Sales &amp; Operations Planning process preparation and facilitation, including interface with Marketing, Sales, Production, Accounting, and other operations groups that are part of this process
• Clearly communicate agreed upon production quantities and mix to Production and other Operations groups. Seamless coordination with Supply Chain Supply Side Planning to meet overall planning objectives
• Manage Zero back order goal – when back order exists full responsibility for back order management, status, prioritization, communication
• Sales and net requirements forecasts review and attainment, holding key geographies accountable to their forecasts thru measurement and communication
• Set and maintain appropriate inventory levels that meet service level objectives to customers balanced with divisional DIOH (Days Inventory On Hand) goals.
• Plan new product introductions and phase outs to achieve planned launch dates with targeted inventory levels
• Facilitate and coordinate key CVD quarterly/annual planning processes like Strat Plan, OP Plan, and quarterly production volume and inventory forecasting
• Monthly inventory management of excess, obsolete, expiring inventory, including developing and implementing solutions to minimize inventory write-offs and communication with Finance on write-off potential.
• Proficient in ERP system functionality to perform job-including driving S&amp;OP agreed upon plans thru MRP to Production for build plans or Purchasing for raw material planning
• Proficient in Excel, PowerPoint and other Microsoft software
Qualifications:
• Bachelor Degree required.
• APICS or other Planning related certifications preferred.
• Minimum 3 years experience in Planning function.
• Medical Device experience preferred.
• Experience with SAP preferred.



|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-03-22 01:48:21</date_new><country>United States</country><company>St. Jude Medical</company><title>Demand Planner</title><state>Minnesota</state><reqid>12664</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>27314756</uid><url>http://jobs.sjm.com/xml/27314756/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Senior Data Warehouse Architect
Job Requisition #: 12605
Date Posted: 03/14/2012
Category: Information Technology
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Senior Data Warehouse Architect will perform necessary duties to design/model, maintain, and optimize multiple data marts and data warehouses within our database environments. The architect will also share responsibilities for Extraction, Transformation &amp; Loading for the data warehouse.

Responsibilities:
• Analysis, design, development &amp; support of the CVD data warehouse environment
• Team member to support Informatica &amp; Business Objects
• Assist in ETL development efforts, making sure that the business rules are implemented correctly
• Diagnose and propose solutions for database and report performance issues
• Other areas of responsibility are Data Strategy, ETL Architecture, ETL development, reference data management and data quality improvement

Requirements:
• Bachelor’s degree
• 8+ years of IT experience
• 5+ years as a Data Architect
• 3-5 years experience with SQL Server
• Full life cycle experience implementing BI architecture and data warehousing solutions
• Strong conceptual, logical and physical data modeling experience
• Performed and led data migration efforts
• Thorough understanding of BI / DW concepts
• Hands on experience in writing, executing and debugging SQL
• Experienced with ER Diagrams and data modeling tools such as ErWin
• Experience with identifying reporting and information requirements
• Excellent communication skills
• Strong analytical, problem solving, and research skills

Preferred Qualifications:
• Medical Device industry exposure or experience
• Working knowledge of Informatica
• Working knowledge of Oracle
• Bachelors degree in CS, Mathematics, MIS, Engineering, etc.



|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-03-14 19:07:30</date_new><country>United States</country><company>St. Jude Medical</company><title>Senior Data Warehouse Architect</title><state>Minnesota</state><reqid>12605</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>27138028</uid><url>http://jobs.sjm.com/xml/27138028/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Senior Clinical Auditor
Job Requisition #: 12534
Date Posted: 02/21/2012
Category: Compliance
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Senior Clinical Auditor will be a member of the Clinical Quality Assurance department within the St. Jude Medical (SJM) CVD Clinical Affairs. The primary responsibility is to implement and maintain written clinical procedures and systems that include a global perspective of medical device clinical trials and quality systems.

Responsibilities:
• Perform clinical audits
• Manage and archive projects and documents
• Communicate with St. Jude Medical departments and operations
• Ensure clinical investigations are designed, conducted and monitored to comply with applicable global requirements
• Train and educate personnel with proper interpretations of regulations and clinical systesm
• Represent St. Jude Medical during agency and/or government inspections for clinical research


Requirements:
• Bachelor's degree preferred; additional relevant work experience in lieu of degree is acceptable.
• 5 yrs experience in Clinical Compliance, Regulatory and/or Clinical Affairs departments in FDA regulated company
• Ability to understand clinical trial activities or have experience conducting clinical trial activities
• Strong understanding and knowledge of the global medical device regulations that interact with clinical trial activities
• Excellent organizational, interpersonal, and communication (verbal/written) skills
• Computer proficiency in Microsoft Office applications, to include spreadsheet/graphics programs
• Extensive working knowledge of national and international practices, guidance, standards and regulations
• Ability to constructively interact with a range of personalities and positions, both inside and outside the organization
• Ability to travel up to 50%



|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-02-21 21:41:32</date_new><country>United States</country><company>St. Jude Medical</company><title>Senior Clinical Auditor</title><state>Minnesota</state><reqid>12534</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>26658163</uid><url>http://jobs.sjm.com/xml/26658163/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Clinical Programs Manager
Job Requisition #: 12409
Date Posted: 02/13/2012
Category: Clinical
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Clinical Programs Manager will manage the successful completion of all clinical programs. Responsible for developing program budgets and hitting both enrollment and spending targets. Staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. Manage the timely development of PMA and other regulatory submissions.

Responsibilities:
Manage the successful and timely execution of all device clinical trials
Responsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations
Responsible for the training, initiation and management of clinical trial sites
Establish and manage trial budgets including enrollment targets
Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending
Participate in the design and development of new trials
Responsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis
Develop and maintain individual training programs for all staff
Able to assist in the drafting and development of publications based on the results of the clinical trials
Develop and maintain strong relationships with principal investigators at clinical trial sites
Travel estimated at15%

Requirements:
BA/BS in life sciences or nursing
10+ years experience in clinical research
5+ years experience successfully managing a team of clinical research professionals
5+ years clinical research experience in medical device
Demonstrated knowledge of and experience with GCP and all US regulations
Hands on experience in IDE clinical trials and the preparation of PMAs
Comfortable in both the clinical and business setting
Comfortable presenting to senior management
Ability to work independently and take direction from others
Strong work ethic
Excellent communication, problem-solving and organizational skills
Computer proficiency including Microsoft Office applications

Preferred Qualifications:
Advanced degree in life sciences or nursing a strong plus
Experience in the cardiovascular therapeutic areas


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-02-13 22:34:16</date_new><country>United States</country><company>St. Jude Medical</company><title>Clinical Programs Manager</title><state>Minnesota</state><reqid>12409</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>26501390</uid><url>http://jobs.sjm.com/xml/26501390/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Clinical Programs Manager
Job Requisition #: 12506
Date Posted: 02/10/2012
Category: Clinical
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Clinical Programs Manager will manage the successful completion of all clinical programs. Will also be responsible for developing program budgets and hitting both enrollment and spending targets. Staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. Manage the timely development of PMA and other regulatory submissions.

Responsibilities:
• Manage the successful and timely execution of all device clinical trials
• Responsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations
• Responsible for the training, initiation and management of clinical trial sites
• Establish and manage trial budgets including enrollment targets
• Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending
• Participate in the design and development of new trials
• Responsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis
• Develop and maintain individual training programs for all staff
• Able to assist in the drafting and development of publications based on the results of the clinical trials
• Develop and maintain strong relationships with principal investigators at clinical trial sites
• Ensure that St. Jude Medical is using the most current tools in the management of clinical trials
• Travel estimated at 30%

Requirements:
• BA/BS in life sciences or nursing
• 10+ years experience in clinical research
• 5+ years experience successfully managing a team of clinical research professionals
• 3-5 years clinical research experience in medical device PREFERABLY
• Demonstrated knowledge of and experience with GCP and all US regulations
• Hands on experience in IDE clinical trials and the preparation of PMAs
• Comfortable in both the clinical and business setting
• Comfortable presenting to senior management
• Ability to work independently and take direction from others
• Strong work ethic
• Excellent communication, problem-solving and organizational skills
• Computer proficiency including Microsoft Office applications

Preferred Qualifications:
• Advanced degree in life sciences or nursing a strong plus
• Knowledge and experience with European and Japan device clinical trials a strong plus
• Experience in the cardiovascular therapeutic areas




|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-02-10 23:21:31</date_new><country>United States</country><company>St. Jude Medical</company><title>Clinical Programs Manager</title><state>Minnesota</state><reqid>12506</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>26467931</uid><url>http://jobs.sjm.com/xml/26467931/job</url></job><job><country_short>USA</country_short><city>Plymouth</city><description>Clinical Research Associate II
Job Requisition #: 12425
Date Posted: 02/07/2012
Category: Clinical
Location: Plymouth - MN - USA


About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?



We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.

Job Overview
The Clinical Research Associate II designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department.

Responsibilities:
• Follows department Standard Operating Procedures
• Sets up sites: clinical research agreements, IRB Approvals, etc
• Prepares and maintains in-service manuals, case report forms, informed consent and other specialized documents for clinical investigations
• Assists Regulatory in annual report and progress reports to the FDA
• Organizes Investigator and Data Safety Monitoring Board meetings
• Reviews data forms and DCF generation
• Conducts field audits to assure protocol compliance and data integrity
• Generates presentations when requested by investigators of AGA personnel
• Generates follow-up reminder reports and sends to investigators or AGA personnel
• Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries
• Acquires professional, product and market expertise via independent reading, networking and training
• Counsels and trains newly hired CRAs and monitors
• Travels approximately 20%
• Participates in professional activities outside of normal business hours
• Performs other related duties as requested

Requirements:
• BA/BS in business, science or nursing
• 2 - 4 years experience in clinical research including monitoring
• Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization
• Excellent written and verbal communication skills
• Ability to work independently and take direction from others


|E-mail this position 
Submit Resume or C.V.</description><date_new>2012-02-08 07:39:11</date_new><country>United States</country><company>St. Jude Medical</company><title>Clinical Research Associate II</title><state>Minnesota</state><reqid>12425</reqid><state_short>MN</state_short><location>Plymouth, MN</location><uid>26394667</uid><url>http://jobs.sjm.com/xml/26394667/job</url></job></source>
