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Clinical Project Manager
Il y a 4 mois
The company:
Join a French company, specializing in the design and manufacture of orthopedic Medical Devices for extremity surgery. The company's mission is to provide simple and innovative solutions to simplify surgical procedures and operating room material management, and to ensure the effectiveness of surgical teams. They offer healthcare professionals innovative solutions in product design as well as in the use of new materials.
Main Mission:
Reporting to the Quality, Regulatory and Clinical Direction, you are responsible for:
- Participating in the clinical evaluation strategy of products under development or already on the market.
- Coordinating the writing of clinical evaluations
- Coordinating the clinical studies.
- Participate in the development of new products as a clinical reference.
- Draft the clinical development plan for new products.
- Conduct clinical literature reviews applicable to their products and compile relevant information on the state of the art, therapeutic alternatives, and existing reference treatments.
- Develop the clinical strategy for clinical evaluation.
- Independently draft clinical evaluation plans and reports, including taking charge of the critical analysis of relevant clinical data.
- Handle statistical analysis of ongoing clinical study data.
- Independently draft pre- and/or post-CE marking clinical investigation plans and reports.
- Independently draft Post-Market Clinical Follow-up (PMCF) plans and PMCF evaluation reports.
- Participate in product risk management as a clinical reference.
Clinical Project Manager
Participate in drafting responses to clinical questions from Regulatory Authorities for ongoing evaluation files.
Your Profile:
- With a master's degree in Engineering, Pharmacy, or equivalent,
- You have 3/5 years of professional experience in a similar position, preferably in the Medical Devices or Pharmaceutical industry.
Required Skills/Qualifications:
- Good knowledge of statistical methods applied to the analysis of clinical data.
- Mastery of written and oral English is essential.
- Ability to engage in your professional activity.
- In-depth knowledge of regulations and standards/guidelines associated with clinical investigations/evaluations (ISO 14971, GCP, ISO 14155, MEDDEV 2.7/1 rev4, European Regulation EU 2017/745 and associated MDCG).
Interested? Apply at monia@talentssolutions.fr
