Sr. Clinical Research Programs Manager

Helping Hearts Heal Themselves

AGA Medical Corporation specializes in the development and manufacturing of innovative medical devices for use in cardiovascular applications. AGA's patented AMPLATZER family of occlusion devices offers new and enhanced solutions for transcatheter treatment of complex congenital heart defects. We are a fast-growing, innovative company, looking for creative professionals to join our team.


The Sr. Clinical Research Programs Manager manages overall operation clinical studies assigned, including project planning, budget, resource management and CRO management.

Duties and Responsibilities:
* Manages clinical operational plan, and incorporates the study and scientific plan.
* May develop study related documents and overall direction for the clinical sites to establish protocol development.
* Manage generation of new clinical investigations.
* Ensures compliance with GCP, and regulatory guidelines.
* Recommends and implements innovative process ideas to impact clinical trials management.
* May develop and manage clinical budget and develop contingency plans for clinical trials.
* Manages clinical trials staff and manages all aspects of clinical operational plan.
* Responsible for managing full scope of study, protocol and scientific publications.
* Acts as a cross functional liaison to ensure study plan aligns with business development strategies.
* Follow department Standard Operating Procedures.
* Ensure Good Clinical Practices and all regulations are followed.
* Oversee Pre-market approval applications and other FDA submissions.
* Develop and maintain a training program for direct reports.
* Assist in publication and/or presentation of clinical data
* Acquire professional, product and market expertise via independent reading, networking and training.
* Additional duties as requested.
REQUIREMENTS
Education, Experience, Personal and Technical Skills:
* BA/BS in business, medical science or nursing (or equivalent experience). Master’s degree preferred.
* Minimum 5-7 years experience in clinical research management, preferably medical device company.
* Knowledge of GCP and all US regulations.
* PMA Clinical Section Reporting experience.
* Ability to interact with a range of personalities and many levels of the organization.
* Ability to work independently and take direction from others.
* Supervision experience; Ability to supervise, direct and train Clinical Research personnel.

Physical Requirements:
•Frequent computer monitor and keyboard use.

For additional company information and other job openings, please visit our website at www.amplatzer.com.

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