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
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