Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 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 Global Clinical Compliance Manager reports to the Associate Director, Clinical Operations and is responsible for supporting the advancement of Abiomed's clinical studies by ensuring clinical quality, process improvements and standard operating procedures (SOP) management along with associated training management.
Primary Duties and Responsibilities:
- Receives global cross functional assignments in the form of objectives and determines how to meet schedules and goals.
- Responsible for the development of all Quality Control Plans/related documents and oversees/performs implementation of quality control activities for assigned projects according to committed timelines.
- Conducts Quality Control activities which include, but are not limited to the following:
- Perform periodic review of clinical trial protocols and associated documentation (including, but not limited to Patient Information, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant Clinical SOPs and regulations.
- Review of Trial Master File to ensure accuracy and completeness of the documentation.
- Independently performs and/or oversees the implementation of integrated and comprehensive data-driven QC activities to ensure compliance with regulatory requirements and SOPs.
- Point person for Quality team regarding the conduct and response to internal and external audits/inspections for Clinical Studies under Clinical Operations.
- Summarizes Quality Control activities, trends, and areas of potential risk to Clinical Leadership.
- Maintains and updates Clinical SOPs, Work Instructions and Policy Documents to ensure they are in alignment with relevant
- Supports Clinical CAPA resolution by taking ownership, when applicable, on the corrective and preventative actions; track and ensure timely resolution of all Clinical CAPAs.
- Actively engages and collaborates with Clinical Trial Managers/Leaders and other members of the Clinical Operations, and cross functionally as applicable, to resolve any identified issues/problems.
- Supports the implementation of new clinical systems/processes as needed.
- Participates in Clinical Trial/Study Core Team meetings, as necessary.
- Provides internal communication of new regulations.
- Establishes themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders.
- Works with departmental leadership and assists in initiatives across Clinical Operations and cross functionally, aimed at improving process and efficiency.
- Serves as the GCP Subject Matter Expert and trainer for Clinical Operations.
- Ensures that clinical trials are conducted in compliance with all applicable Regulations, Guidelines and compliance with CFR.
- Ensures that internal processes and procedures meet the requirements of GCP, PHI practices, EU MDR, etc.
- Recommends changes to policies and establishes procedures that affect Clinical Operations.
- A minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years' experience; or equivalent experience
- Working knowledge of US & OUS regulations required (specifically Europe and Asia)
- Previous internal/external clinical auditing experience preferred
- Working knowledge of clinical trial operations required; Cardiology experience preferred
- Proven success working collaboratively with diverse stakeholders across a global organization
- Outstanding communication skills, verbal and written
- Highly organized and detail-oriented
- Ability to be independent, multitask and results-oriented with a hands-on attitude in a fast-paced and energetic environment
- Strong presentation skills and technical audio-visual knowledge
- Highly proficient in Microsoft Office Suite
Applicants must provide proof that they are fully vaccinated with an FDA approved or authorized vaccine for COVID-19 or have a valid medical/religious exemption
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.