Clinical Project Manager

Nouvelle opportunite : Clinical Project Manager chez Symbios Orthopédie S.A. (Yverdon-les-Bains).

Nous recrutons un Clinical Project Manager pour notre département RA & QA.

Tâches

• Diriger les essais cliniques mondiaux selon ISO 14155 et GCP.
• Rédiger et revoir les protocoles d'investigation clinique et documents.
• Suivre et maintenir la documentation des essais prête pour audit.

Compétences

• Diplôme en technologie médicale ou sciences de la vie, 5 ans d'expérience.
• Autonome, capacité à juger en fonction des connaissances réglementaires.
• Bilingue français-anglais, l'allemand est un atout.

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.

Rejoignez Symbios Orthopédie S.A. et donnez un nouvel elan a votre carriere.