Clinical Project Manager - #47076

1400 Yverdon-les-Bains, Suisse Posté il y a 19 heures

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.