Clinical Project Manager

vor 3 Wochen


Geneve, Schweiz Axepta SA Vollzeit

We are looking for a **Clinical Project Manager**, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices, located in Geneva.

Be part of the young and dynamic Clinical Research Department for the implementation of clinical studies to ensure compliance with regulations (MDR, FDA...).

**Responsibilities**:
You will be responsible for planning and managing clinical studies while respecting deadlines, budgets and quality standards.

Your main responsibilities will be:

- Implementation, execution and completion of company clinical research projects.
- Responsible for compliance with local regulations, GCP regulations and CRO SOPs in clinical projects.
- Selection and validation of investigators/sites and vendors (e.g. CROs).
- Contribute to the negotiation and preparation of contracts and budgets with third parties and study sites
- Ensure high quality documentation throughout the clinical study.
- Manage essential clinical documentation for regulatory and ethics committee submissions in the US.
- Manage CROs and ensure that they meet their time and budget commitments.
- Management of clinical study budgets, including site agreements/budget.
- Oversight of research organization performance and/or co-monitoring visits to sites participating in sponsored clinical projects.
- Communicate regularly with sites participating in clinical projects.

**Your profile**:

- Scientific background (e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science)
- A minimum of 4 years' experience in Clinical Operations and project management (covering all stages of a clinical study)
- Experience with medical devices studies
- Fluent in English required / French is a plus



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