Clinical Project Manager

Symbios Orthopédie S.A. est a la recherche d'un(e) Clinical Project Manager pour son site de Yverdon-les-Bains.

Nous recrutons un Clinical Project Manager pour notre département RA & QA.
Tâches
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Diriger les essais cliniques mondiaux selon ISO 14155 et GCP.
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Rédiger et revoir les protocoles d'investigation clinique et documents.
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Suivre et maintenir la documentation des essais prête pour audit.
Compétences
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Diplôme en technologie médicale ou sciences de la vie, 5 ans d'expérience.
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Autonome, capacité à juger en fonction des connaissances réglementaires.
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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:
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Lead operational execution of global clinical trials (ISO 14155, GCP), including clinical site management and monitoring activities.
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Write and/or review clinical investigation protocols and research documents, ensuring data collection needs are met and compliance with applicable regulations.
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Track, collect and maintain audit-ready trial documentation, including regulatory submissions and study-specific essential documents.
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Develop and maintain the global Symbios post-marketing studies database, including CRF design and data validity checks specifications.
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Support the Clinical Affairs Manager in responding to Competent Authorities (Belgium, France, UK and Germany), physicians and other requesters on Clinical Studies topics.
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Support strategic market access and rebate processes (USA, Australia), and data analysis/statistical activities for publication purposes.
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Define project targets for external partners and ensure work is documented within the contracted project scope.
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Coordinate and oversee the clinical monitoring team (external partner), managing CRA performance and project milestones proactively.
Profile we are looking for:
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A Bachelor's or Master's degree in medical technology, life sciences, Clinical Affairs or equivalent work experience in a similar function.
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Minimum 5 years of experience in the medical device field (preferably in orthopedics), with a specialization in regulatory (MDR requirements), Quality and Clinical Affairs.
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Prior experience as trial/study manager or strong background as Lead CRA.
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Good knowledge of ISO 14155 and ICH GCP requirements.
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Able to work autonomously and exercise daily judgment based on regulatory/clinical knowledge.
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Result-oriented with demonstrated organizational and planning skills based on team priority.
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General computer skills (PC, Microsoft Word/Excel/PowerPoint, Outlook/Teams).
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Able to travel frequently in Europe.
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Languages: French fluent / English fluent / German fluent would be an asset.
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Valid Swiss work permit required.

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