The Sr Clinical Research Operations Manager is responsible for executing Abiomed clinical research strategy. This leader is responsible for the operations of the execution of Abiomed clinical trials and registries and ensuring the trials are conducted in accordance to GCP (Good Clinical Practice) guidelines and FDA regulations.  The Sr of Clinical Operations Manager works closely with the Chief Medical Officer, Medical Affairs and Regulatory Departments to ensure the successful conduct of Abiomed studies and registries.  The Sr Clinical Research Operations Manager typically manages a staff of Clinical Project Managers and Clinical Research Associates, as well as external vendors such as CROs, Corelabs, and Medical Monitors/DSMBs.  The position provides the Clinical Operations department interface to executive management and is a highly visible role in Abiomed.

Primary Duties and Responsibilities:

1. Develop and implement daily clinical research operations to meet corporate goals and objectives in a fast pace environment. Coordinate department planning to ensure that the Clinical Operations department functions optimally and within budget.
2. Ensure that Clinical Operations department interfaces with key functional groups (Medical Affairs, R&D, Manufacturing, Sales, Marketing, Regulatory Affairs in US, as well as Japan and European Clinical Groups) to drive clinical wide or cross-departmental initiatives.
3. Procure and oversee outside vendors and consultants as required. In particular, leadership of a large outside CROs including the use of the internal resources to provide specifications, scope of work, budgeting limits and execution direction.
4. Work in collaboration with Regulatory Affairs to prepare clinical summaries for IDEs, 510(k) s, PMAs and related regulatory filings.
5. Coach and develop Clinical Project Managers and other direct reports with all aspects of their responsibilities.
6. Provide operational and management level representation during internal and external audits.
7. Oversee the clinical department SOP review and development, employee training, and associated requirements.
8. Maintain knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Abiomed products.

Job Qualifications:

Technical

• Proven track record (5+ years of experience) in similar role required with an emphasis on organizational and operational excellence.
• Multiple years experience in managing programs as the main interface with outside CRO groups in Class III cardiovascular devices.
• Reasonable knowledge of medical terminology.  Experience in cardiovascular studies would be a strong advantage.
• Expertise with GCP and regulatory compliance guidelines for clinical trials required
• Advanced, metric driven project management skills.

Conceptual

• Positive, self-starter person looking for growth and making a difference in patient lives
• Willing to work in an extremely fast pace environment who would embrace the opportunity to juggle many projects and hats.
• High attention to details and accuracy.
• Excellent prioritization and organizational skills.

Interpersonal

• Advanced people management skills and empathy.
• Positive flexible outlook. Proactive and able to think outside the box and almost predict the future.
• Excellent interpersonal communication skills.
• Works effectively on cross-functional teams.
• Presents professional manner and appearance.

Educational Requirements:

• Bachelor’s degree in biological sciences or related medical/scientific field with a minimum 10 years clinical research experience with 5 at least in the medical device industry.
• Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience. 

ABIOMED is an Equal Employment Opportunity/Affirmative Action employer.  We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.