FAQ
AGA Medical Corporation, a medical technology company, is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.
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Clinical Programs Manager
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| City: Plymouth
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Relocation Available: TBD |
| State/Province: MN
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| Country: United States |
Type (Duration): Regular, Full Time
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| Job Number: 1587 |
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| Functional Area: Clinical
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| Division: Clinical |
Work Hours: |
As the Clinical Programs Manager, you will manage the successful completion of all Pediatric and Post Approval clinical programs for AGA Medical as well as be responsible for developing program budgets and hitting both enrollment and spending targets. You will staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. The Clinical Programs Manager will build and maintain relationships with clinical trial sites and principal investigators plus develop and maintain tools for tracking progress against department goals and objectives. You will participate in the design of new trials and the selection of trial sites ad well as manage the timely development of PMA and other regulatory submissions.
Responsibilities:
- Manage the successful and timely execution of all device clinical trials for AGA Medical.
- Select, train and manage all Clinical Research Associates including their training and compliance with all SOPs and associated regulations.
- Lead 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.
- Develop the 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.
- Assist in the drafting and development of publications based on the results of the clinical trials.
- Ensure all staff maintain relevant professional certifications and remain current with the latest development in interventional cardiology and structural heart defects.
- Develop and maintain strong relationships with principal investigators at clinical trial sites.
- Ensure that AGA Medical is using the most current tools in the management of clinical trials.
Qualifications:
- BA/BS in life sciences or nursing.
- Advanced degree in life sciences or nursing a strong plus.
- 5-10 years experience in clinical research management, preferably medical device company developing products for use in interventional cardiology.
- Demonstrated and successful management experience of a clinical team of a minimum of 5-10 professionals.
- Demonstrated knowledge of and experience with GCP and all US regulations.
- Knowledge and experience with European and Japan device clinical trials a strong plus.
- Hands on experience in the preparation of PMAs and 510(k)s or equivalent non-device regulatory submissions.
- 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 and willing to travel up to 30%.
- Excellent communication, problem-solving and organizational skills.
- Computer proficiency including Microsoft Office applications.
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Submit Application
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We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more.
An Equal Opportunity / Affirmative Action Employer
Please, No Agencies.
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Contact Us
AGA Medical Corporation
5050 Nathan Lane North
Plymouth, MN 55442
USA
Toll Free: 1-888-546-4407
Phone: 1-763-513-9227
Fax: 1-763-513-9226
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