Job Description:

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, and offices in Baltimore, MD, 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

Reporting to the Manager, Clinical Trial Coordination and is responsible for the oversight, growth, and development of our in-house Clinical Trial Coordinators. The Lead Clinical Trial Coordinator works in collaboration with the Manager, Clinical Trial Coordination and is expected to oversee clinical trial coordinator activities including accelerating site start-up, maintenance and closeout activities related to electronic trial master files through the development and execution of Clinical SOPs and processes in support of Clinical Trials. This person will train, manage, and develop Clinical Trial Coordinators to ensure clinical trials are conducted in a controlled, compliant way, such that safety and privacy of subjects is ensured with the highest level of data quality and integrity.

Principle Duties and Responsibilities:

• Responsible for hiring, training, and retaining a diverse group of Clinical Trial Coordinators, ensuring adherence to pertinent regulations through regular review of eTMF system metrics, Trial Master File review, communications with cross functional stakeholders and others as needed


• Accountable for the development of direct reports through performance reviews, instruction, mentoring and coaching. This includes setting goals, conducting periodic and year end performance reviews, proactively identifying, and addressing any areas of concern, providing development opportunities to team members, and as needed, escalating performance and/or personnel issues


• Lead in the development of technical training on GCPs, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities


• Supports Manager, Clinical Trial Coordination in managing the integration of clinical trial coordination activities including CTC site start-up metrics, along with optimizing CRO resources (when necessary)


• Effectively communicate and interact with cross-functional stakeholders


• Maintains an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education


• Participates in inspection readiness activities and audit activities performing Trial Master File (TMF) audits on a regular basis


• Supports Manager, Clinical Trial Coordination to ensure that all relevant CAPAs are adequately developed, reviewed, and implemented


• Facilitates collaborative environment through team building activities and leadership

Job Qualifications:

• Bachelor's Degree is required


• 3+ years of clinical research experience gained at a CRO, Medical Device or Pharmaceutical Company working on early feasibility trough post marketing global clinical studies


• Strong regulatory knowledge, including Good Clinical Practices (GCPs)


• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning, and problem-solving ability


• Excellent communication (written and verbal) and presentation skills along with leadership qualities


• Experience with ICF development and review and managing electronic trial master files


• Strong organizational skills and ability to deal with competing priorities


• Proficient with MS Office Suite (Excel, Word, and PowerPoint)


• Ability to be independent, multitask and results-oriented with a hands-on attitude in a fast-paced and energetic environment

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.Abiomed maintains a drug-free workplace.

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