Company logo

Clinical Affairs Manager

Coopers Group AG
Vaud

3T

Clinical Affairs Manager


For our medtech client in Lausanne region we are looking for a 

Clinical Affairs Manager

Description:

The Clinical Affairs Manager is responsible for clinical studies, clinical evaluation, post market surveillance and validation/usability.

Your role:

  • Design of clinical trials including protocol development, clinical trial discussions with regulatory authorities, and development of timeline and budget.
  • Manage the process of screening, qualifying, and selecting, and contracting with investigators, sites and vendors required for conduct of clinical trial.
  • Obtain necessary clinical trial approvals from EC’s/IRB’s and regulatory bodies such as the Competent Authorities and FDA.
  • Ensure studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.
  • Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
  • Maintain surveillance of published literature and clinical results and competitive products across all pertinent indications for strategic purposes and use in regulatory submissions.
  • Develop, maintain, and expand collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs.
  • Develop SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to GCP regulations and standards.
  • Ensure adherence to protocols and compliance with regulatory (MDR/FDA/ICH/GCP) guidelines as well as SOP procedures.
  • Identify clinical training needs and develop training materials for in-house and clinical site use.
  • Provide oversight of investigator-sponsored studies.

Required profile:

  • Degree in medical, natural sciences, technical or life sciences or related disciplines.
  • 3+ years direct experience in clinical trial management.
  • Solid track record in successfully executing clinical trials.
  • Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations.
  • Experience in managing CROs, Core Labs, Data Management, Biostatistics, and Medical Affairs Safety Reporting.
  • Knowledge of electronic data capture systems and web-based clinical trial management tools.
  • Excellent interpersonal, written / verbal communication & organizational skills.