1400 Yverdon-les-Bains, Suisse
Posted 3 days ago
We are currently looking to recruit a key role in our RA & QA & Clinical Affairs department:
Clinical Project Manager
The Clinical Project Manager supports the Clinical Affairs department by coordinating and executing sponsored clinical studies from planning through close-out and archiving. This role requires a hands-on Clinical Project Manager capable of independently managing global studies for Symbios medical devices, according to EU MDR, ISO 14155 and other applicable regulations.
Key responsibilities include:
- Lead operational execution of global clinical trials (ISO 14155, GCP), including clinical site management and monitoring activities.
- Write and/or review clinical investigation protocols and research documents, ensuring data collection needs are met and compliance with applicable regulations.
- Track, collect and maintain audit-ready trial documentation, including regulatory submissions and study-specific essential documents.
- Develop and maintain the global Symbios post-marketing studies database, including CRF design and data validity checks specifications.
- Support the Clinical Affairs Manager in responding to Competent Authorities (Belgium, France, UK and Germany), physicians and other requesters on Clinical Studies topics.
- Support strategic market access and rebate processes (USA, Australia), and data analysis/statistical activities for publication purposes.
- Define project targets for external partners and ensure work is documented within the contracted project scope.
- Coordinate and oversee the clinical monitoring team (external partner), managing CRA performance and project milestones proactively.
Profile we are looking for:
- A Bachelor's or Master's degree in medical technology, life sciences, Clinical Affairs or equivalent work experience in a similar function.
- Minimum 5 years of experience in the medical device field (preferably in orthopedics), with a specialization in regulatory (MDR requirements), Quality and Clinical Affairs.
- Prior experience as trial/study manager or strong background as Lead CRA.
- Good knowledge of ISO 14155 and ICH GCP requirements.
- Able to work autonomously and exercise daily judgment based on regulatory/clinical knowledge.
- Result-oriented with demonstrated organizational and planning skills based on team priority.
- General computer skills (PC, Microsoft Word/Excel/PowerPoint, Outlook/Teams).
- Able to travel frequently in Europe.
- Languages: French fluent / English fluent / German fluent would be an asset.
- Valid Swiss work permit required.
