Job Opportunity: Clinical Project Manager
We are seeking a talented professional to join our RA & QA & Clinical Affairs department as a Clinical Project Manager. In this pivotal role, you will support the Clinical Affairs department by coordinating and executing sponsored clinical studies from planning through to close-out and archiving. We are looking for a hands-on Clinical Project Manager capable of independently managing global studies for Symbios medical devices in accordance with EU MDR, ISO 14155, and other applicable regulations.
Key Responsibilities
- Lead the 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), as well as 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), proactively managing CRA performance and project milestones.
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.
- A minimum of 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 a trial/study manager or a strong background as a 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 priorities.
- General computer skills (PC, Microsoft Word/Excel/PowerPoint, Outlook/Teams).
- Able to travel frequently within Europe.
- Languages: Fluent in French and English; German would be an asset.
- Valid Swiss work permit required.
Apply online using the form below. Please note that only applications matching the job profile will be considered.