Abiomed has the immediate opportunity for an exceptional, motivated clinical study leader to join the quickly-growing Clinical Operations team. This is an exciting and highly-visible opportunity to lead ground-breaking studies that will continue to shape the field of Heart Recovery!
In this newly created role, The Senior Clinical Program Manager will represent the Clinical Operations team both internally and externally in managing the successful full-cycle execution of key clinical studies. Reporting to the Director of Clinical Programs, the Senior Clinical PM is responsible for setting the vision for and executing an Abiomed Clinical Study(ies). This leader ensures that the clinical study they are managing is conducted in accordance with GCP/ICH guidelines and FDA regulations.
Primary Duties & Responsibilities:
Create the strategic vision for, manage and execute a highly-complex study for a Class III device
Effectively manage a study that enrolls high-risk patients in a fast-paced environment
Conduct clinical research programs in accordance with approved project plan
Comprehensive study management for clinical study, including but not limited to:
protocol and database development
site management and monitoring
Provide leadership and program representation internally & externally
Manage Governance Committees meetings
Provide regular Study Status Reports to cross-functional Leadership teams
Quality Assurance support and management-level representation during audits and inspections
In collaboration with Director, procure & oversee outside vendors and consultants
Develop and implement daily clinical research operations related to the study to meet corporate goals and objectives within budget
Collaborate with Regulatory Affairs to prepare clinical summaries for IDEs, 510(k)s, PMAs and related regulatory filings
Maintain compliance to company standard operating procedures (SOPs) and applicable regulations
Maintain knowledge of competitive technologies in addition to medical, technical and biomedical developments related to Abiomed products
BS degree in Science, Engineering, or directly applicable medical/scientific field
10+ years of clinical research experience, including global / international experience
3-5 years of medical device clinical research experience
Expertise in Good Clinical Practice (GCP) & regulatory compliance guidelines for clinical trials
Direct experience successfully conducting Pre/Post-Market Clinical strategies to align with business objectives
Willingness and ability to travel up to 30-35% of the time (Sites, Vendors, Conferences)
Class III medical device experience preferred; experience with Class III cardiovascular devices strongly preferred
MS or graduate degree
Experience with site and sponsor level FDA BIMO investigation(s)
Certified Clinical Research Professional (CCRP) and/or Project Management Professional (PMP)
Internal Number: 4573
About Abiomed, Inc.
Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,400 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.