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CLINICAL AFFAIR MANAGER

AcuSurgical is an early-stage surgical medical device innovator conducting clinical trials to commercially launch its products.  The Clinical Affairs Manager is responsible to execute AcuSurgical’s clinical studies in compliance with local and regional regulations, company SOPs, and study protocols.

LOCATION

Montpellier, France

EMPLOYMENT TYPE

Permanent

What You’ll Do

Responsible for clinical studies operation; may include one or several clinical trials; reports to Director of Clinical Affairs :

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  • Ensure clinical trial set-up

  • Participate in delivery of required study documentation (Protocol, Budget, Contract, IRB, etc.) and on-site training

  • Prepare and conduct clinical investigator’s team meetings

  • Monitor clinical study progresses (patient enrollment and consent, progress of data collection, adherence to the study protocol & inclusion-exclusion criteria, regulatory requirements, audit of safety data, etc.)

  • Coordinate CRO activities, and ensure liaison between sites and CRO to foster robust patient enrollment, scheduling of procedures, availability of investigational devices, data collection via CRFs, data reporting, reconciliation of investigational device inventory

  • Oversight of clinical study procedures at the clinical sites,

  • Maintain Trial Master File; ensure currency, compliance of documentation

  • Oversee clinical study data collection; ensure data integrity and pertinence.

  • Manage site budget and payment

  • Report to management on Protocol adherence issues, site feedback on Investigational Product and propose adequate measures as required.

  •  Ensure diligent safety reporting to management

  • Participate in maintenance of clinical SOPs

  • Participate in clinical standard watch

Who You are

  • Bachelor’s degree in Life Sciences, Nursing, Engineering, Master’s degree preferred

  • At least 5 years of clinical study management experience in support of pre- and post-market clinical study of medical devices or surgical procedures. Statistical expertise is a plus.

  • Ability to travel (frequent travels to clinical sites are expected)

  • Ability to manage time and identify priorities, and to work independently with creative problem-solving approach

  • Strong communication and interpersonal skills, team player and passionate toward achieving goals

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