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Manager, Global Clinical Compliance

Date:  May 3, 2022
Location: 

Danvers, Massachusetts, US

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
 

The Manager, Global Clinical Compliance is responsible for ensuring that clinical studies are executed in accordance with applicable international, federal, and local regulations, Good Clinical Practices (GCP), and Abiomed internal Standard Operating Procedures (SOPs).  She/he will serve as a resource for clinical study teams to instill regulation awareness and promote a constant state of inspection readiness, inclusive of identifying potential risks and advising on solutions to ensure high quality clinical evidence is generated in support of clinical study tactical plan objectives.  She/he will conduct routine quality checks of clinical studies to ensure that quality records are accurate, complete, and contemporaneous.  She/he will take an ownership role of the Clinical Quality System, ensuring alignment with regulations, GCP, and corporate quality standards; leveraging internal subject matter experts (SMEs) to develop content aligned with current practice, and developing effective training programs to ensure that associates have the knowledge and skill to perform their essential duties.  The Manager, Global Clinical Compliance will work closely with Quality Assurance to manage health authority inspections, schedule and align on internal audit objectives, and manage Corrective and Preventative Actions (CAPA).

 

Principle Duties and Responsibilities:

  • Actively engages and collaborates with Clinical Program/Project Managers, Clinical Affairs Leadership, and other members of the internal study team to promote inspection readiness throughout the full clinical trial lifecycle.
  • Identifies potential risks and advises team on solutions to ensure regulatory compliance and transparency.
  • Escalates compliance risks and effectively communicates concerns with Clinical Affairs Leadership as appropriate.
  • Schedules and conducts routine quality checks of clinical studies to ensure that quality records are accurate, complete, and timely.
  • Develops risk-based quality driven strategies to identify, measure, and mitigate clinical study risks that are aligned with regulatory status and project scope.
  • Conducts training for Clinical Affairs on regulations, guidance documents, and effective management of audits.
  • Develops training plans to ensure associates have the knowledge and skill to perform their essential duties; monitors compliance to training plans.

 

 Job Qualifications:

  • Bachelor’s degree from an accredited university required; BS preferred in Life Sciences or related medical/scientific/technical field.
  • Minimum 8 years of professional experience in a functional capacity in a CRO, pharmaceutical, biotechnology, or medical device company; Clinical Operations, Monitoring or Project Management preferred
  • Minimum 4 years of experience supporting medical device studies.
  • Prior Compliance/Quality experience preferred.
  • Advanced Knowledge of GCP and FDA Code of Federal Regulations (21 CFR Part 11, 50, 54, 56, 812) required.
  • Intermediate Knowledge of International Regulations (EU MDR, ISO, Japanese GCP (J-GCP), Japanese Electronic Records/Electronic Signatures (ER/ES)) required.
  • Knowledge of data privacy concerns including European General Data Protection Regulation (GDPR) required.
  • Knowledge of clinical trial applications, including prior knowledge and experience with Veeva Vault eTMF and Medidata RAVE.

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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.