Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

Reporting to the Associate/Director, Clinical Programs, the Clinical Site Manager is responsible for the functional management of day-to-day aspects of site activities on assigned clinical trials. The Site Manager should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as a collaborative team.

Principle Duties & Responsibilities:

• Serve as Subject Matter Expert (SME) for monitoring and site management activities conducted on assigned clinical studies
• Review of study level trends, escalations, and action items to ensure overall site management efficiency
• Review monitoring visit reports to ensure compliance with Abiomed procedures and study plans
• Serve a critical role as liaison and facilitate meetings between project stakeholders to ensure study tasks and deliverables are on track
• Provide direction and guidance to execute project deliverables in collaboration with project/program managers
• Provide strategic direction on field monitoring of studies and dat acollection for clinical trials with increased volume and complexity (e.g KOL site), act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consisteny with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping protocols, GCP (Good Clinical Practice) and regulatory requirements
• Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, Resolve complex trial/study data and regulatory documentation discrepancies escalated by junior level employees
• study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities
• Develop Clinical Research Associates to increase business acumen and functional skills; act as a mentor to new or junior level employees
• Support the development of site training, recruitment, and required study related content and materials
• Support CRAs through study start up process, ensuring collection of appropriate documentation and timely review of documentation including but not limited to budgets, clinical research agreements and informed consents
• Participate in development and validation of case report forms, when applicable
• Review and complete checklist on informed consent forms (ICF), as needed
• Develop a familiarity with the protocols to ensure adherence to study timelines, inclusion and exclusion criteria, and enrollment goals
• Support of review of Standard Operating Procedures (SOPs); Work Instructions and engagement in process improvement initiatives
• Supports conduct of Site Initiation Visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
• Supports conduct of Site Monitoring (Site Management or Interim Monitoring Visits) Visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
• Supports conduct of Site Close-out Visits and follow-up to ensure all site related activities and documents are complete and filed in the eTMF
• Develop tools, trackers, and project specific training materials
• Assist in the auditing of clinical trials

Job Qualifications:

• Bachelor's Degree or equivalent in related field with at least 3-5 years previous field monitoring experience or 2 -3 years project management experience, quality assurance/control and regulatory compliance required
• Prior experience supporting trials for Class II/III medical devices
• Experience with electronic data capture and Clinical Trial Management Systems required
• Proven expertise in MS Office Suite, including Word, Excel, and Adobe
• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving, organizational, analytical, and critical thinking skills
• Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA/Project Management certification) preferred
• Master's Degree or equivalent with Experience working in a regulated industry preferred
• Ability to travel up to 50%, as required

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.