Clinical Operations Manager

Watertown, Massachusetts, United States | Full-time

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The Clinical Operations Manager will lead the strategic direction and operational aspects of clinical trials for Affera’s Class II and III medical devices. This position will be responsible for developing and implementing clinical evaluation plans from feasibility through pivotal clinical trials to support regulatory submissions.

 

Candidate must be willing to relocate to Boston. Relocation assistance is available.

 

Responsibilities

  • Develop strategic direction and priorities for clinical evaluation, including objectives, work plans, milestones and deliverables.
  • Design and execute pivotal clinical trials in line with Affera SOPs, Good Clinical Practice, and relevant regulations and guidance, including prioritizing indications, choosing appropriate populations and endpoints, planning statistical analysis, and identifying risks and benefits.
  • Provide overall clinical site management from qualification/start-up to closeout, including contracting, training, site initiation, monitoring, and reports.
  • Lead in selection and management of third party vendors (CROs, core labs, etc.).
  • Review, interpret and disseminate study data for publications and reports.
  • Oversee all vendor budget activities, investigator payments, clinical trial agreements.
  • Work with the Data and Safety Monitoring Committee and Clinical Events Committee to adjudicate events, interpret results, and provide trial oversight.
  • Prepare clinical investigation/evaluation reports and contribute to regulatory submissions.
  • Work cross-functionally with Quality, Regulatory Affairs, and Engineering teams, as appropriate to support efforts in these areas.

 

Preferred Qualifications and Experience

  • BS or higher in a technical or clinical discipline (engineering, biology/life sciences).
  • 5+ years clinical research experience in a medical device setting.
  • Previous experience in a pivotal IDE trial with a cardiovascular device.
  • Experience with managing clinical operations for a small company/start-up preferred.
  • Experience with Electronic Data Capture (EDC) systems.
  • Demonstrated experience with major regulatory submissions – PMA, CE mark, 510(k), etc.
  • Excellent analytical skills required; some formal training in statistics is preferred.
  • Positive, self-motivated, detailed, and hands-on, with the ability to work independently as well as collaboratively in a start-up environment.