Manager, CEC Operations

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, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 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.

Patients First | Innovation | Winning Culture | Heart Recovery

This position will be responsible for management of all aspects of the clinical events committee (CEC) operations.

Responsibilities include: Manage medical and clinical reviewers to generate event dossiers, and facilitate CEC activities on-plan and on-time. Collaborate with external stakeholders (CEC members, CROs, AROs) on the deliverables.

Job Responsibilities:

• Managerial skills: Effective employee management, development, including goal settings, performance reviews, mentoring, development, and ability to assess employee’s soft skills such as efforts and attitudes
• CEC: Manage development of study specific CEC charters
• Manage work flow and processes for all aspects of CEC adjudication;
• Define source document (SD) requirements and provide feedback regarding any deficiencies or discrepancies between SDs and CRFs;
• Ensure consistency in application and consideration of definitions over time and by all CEC members;
• Ensure CEC member questions are addressed relative to individual events and surrounding circumstances (co-morbidities, evidential proof, etc.);
• Facilitate review of all physiological data available during meetings;
• Support reconciliation of all adverse events for endpoint criteria, completed adjudication, database entries and quality control;
• Integrate activities with Project Management/Study Team to achieve study milestones
• Accountable for the design, authoring, implementation, and execution of standard operating procedures (SOPs)
• Responsible for audit readiness in CEC related activities
• Responsible for scheduling, training, contracting, and maintenance of CEC member documentation

Job Requirements:

• Bachelor’s degree in medical sciences, clinical degree preferred
• Minimum 3 year of experience in (medical device/pharma/biotech) CEC operations and medical safety; experience in managing CEC is preferred
• Minimum 2 years of employee management; ability to work with a minimal amount of supervision
• Effective analytical and problem-solving skills; willing to develop strong knowledgebase in mechanical circulatory devices
• Excellent written and communication skills
• Travel: May require travels in US, and international travel (~10%) of the time.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.