P2609 - Senior Trial Master File (TMF) Specialist

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., * 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.

• 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.

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique "development only" business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target. We are currently looking for a motivated and collaborative professional to join our Global Clinical Operations Department (R&D) based at our Headquarters in Lausanne, Switzerland as, * 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