Senior Trial Master File (TMF) Specialist
Permanent role | Lausanne, Switzerland
Your Mission: Ensuring Excellence and Inspection-Readiness of Clinical Trial Documentation
As a Senior TMF Specialist, you will be the guardian of our Trial Master Files, supporting Clinical Trial Teams from trial setup through to final archiving. Your role is critical in ensuring that our clinical documentation is compliant, of the highest quality, and always ready for regulatory inspection.
Your Key Responsibilities
* eTMF Stewardship: Serve as the Clinical Business Administrator for the Debiopharm eTMF system, providing first-line support to the users and contributing to validation activities.
* Quality & Oversight: Drive the health of the TMF by implementing risk-based quality reviews and overseeing TMF completeness for both internal and outsourced trials.
* Metrics & Performance: Establish KPIs and report on TMF quality and performance to help Clinical Trial Teams maintain high standards of oversight.
* Inspection Readiness: Support the teams during audits, inspections, and due diligence activities.
* Continuous Improvement: Identify improvement opportunities, drive cross-functional TMF initiatives, and contribute to the evolution of SOPs and training tools.
* Expert Guidance: Provide ongoing training and guidance to team members to build global awareness of TMF regulatory requirements.
Your Profile
* Education: Bachelor’s or Master’s degree in Science, Healthcare, or equivalent experience in a relevant discipline.
* Experience: At least 3 years in the pharmaceutical industry, with hands‑on experience in clinical trials and TMF documentation/systems.
* Expertise: Solid knowledge of Good Clinical Practice (GCP) and advanced proficiency in managing digital clinical systems.
* Languages: Fluent in English; proficiency in French or another European language is a distinct asset.
* Soft Skills: A strong communicator and team leader capable of building effective relationships across internal and external functions. You are highly organized, detail-oriented, and excel at planning.
What we Offer:
* Being part of a company where innovation, collaboration, and impact aren’t just values— they’re how we work every day.
* Partner with teams across disciplines, at the forefront of oncology and anti‑infective development.
* An inclusive and respectful workplace— proud to be Equal‑Pay certified.
* Grow in a culture that values people, purpose, and performance.
* A chance to grow, share, and shape the future of healthcare.
#J-18808-Ljbffr