The Clinical Project Manager is responsible for executing Abiomed clinical trials and/or registries. This leader ensures that the clinical study(ies) he/she is charge of is (are) conducted in accordance with GCP (Good Clinical Practice) guidelines and FDA regulations. The Clinical Project Manager reports into the Director of Clinical Research Operations, the Medical Affairs group and Regulatory Department to ensure the successful execution of the studies within timeline and budget. This position may also need to manage CROs that execute the study operations, the Corelabs and Medical Monitors/DSMBs. This is a highly visible role in the organization.
Primary Duties and Responsibilities:
Work in collaboration with Regulatory Affairs to prepare clinical summaries for IDEs, 510(k) s, PMAs and related regulatory filings
Manage and execute highly complex studies with Class III devices that enroll high-risk patients in a fast paced environment
Develop and implement daily clinical research operations related to the study(ies) being managed to meet corporate goals and objectives and within budget
Procure and oversee outside vendors and consultants; 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. Daily management of the CRO activities is of critical importance to the study success
Interface with rest of the Clinical Operations department, Medical Affairs, R&D, Manufacturing, Sales, Marketing, Regulatory Affairs
Ensure high compliance within GCP across all study activities and documentation
Provide operational and management level representation during internal and external audits related to the study
Maintain knowledge of competitive technologies in addition to medical, technical and biomedical developments related to Abiomed products
Skills/Requirements
Job Qualifications:
BS degree in biological sciences or related medical/scientific field; MS substitutes for 1 year of experience
Minimum of 7 years' experience in clinical research with at least 3 years in the medical device industry
Proven track record (4+ years of experience) in similar role required with an emphasis on organizational and operational excellence
Multiple years' experience in managing clinical studies with successful experience in managing outside CRO in Class III cardiovascular devices
Reasonable knowledge of medical terminology; experience in cardiovascular studies is a strong advantage
Expertise with GCP and regulatory compliance guidelines for clinical trials required
Advanced, metric-driven project management skills
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
Excellent interpersonal communication skills
Works effectively on cross-functional teams
Presents professional manner and appearance#LI-#LI-PH1PH1
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.
