Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Clinical Operations team in the Research and Development department based in Lausanne we are looking for a:
BIOSAMPLE COORDINATOR (100% - permanent contract)
In this role, you will work in a multidisciplinary matrix organization and contribute to the development of new therapeutics. As Biosample Coordinator you will manage the operations and logistics necessary to execute the testing, analysis, and storage of biological samples for clinical trials and translational projects in compliance with relevant regulations.
Your main responsibilities:
- Work in matrix organization in close collaboration with the Clinical Operations team and Translational Medicine functions (Pharmacology and Screening, Clinical Pharmacology & Drug Metabolism, Preclinical Safety and Diagnostics/Personalized Medicine) to manage sample tracking, receiving, and storage processes for clinical and translational projects.
- Support clinical study activities in the preparation and review of study-related documents (such as ICF, CRF, laboratory manual, DTS, etc.).
- Interface with laboratory personnel, sample processing vendors, and other vendors (e.g. vendor for long term storage) as needed to ensure proper shipment of samples, respond to issues as needed, and to ensure study objectives are met.
- May contribute to the assessment of site and lab feasibility for biological sample collection, handling and storage.
- Be responsible for the development and maintenance of a biorepository database for human and non-human biological samples.
- Ensure biosample process consistency across clinical studies within their respective projects and manage sample logistics from patient to data, in compliance with GXPs.
- Participates in process improvement projects (SOPs, work instructions, training materials) in collaboration with QA and clinical study teams.
- Forecasts the biosample operational costs and review contracts and invoices.
- Hold a degree in life sciences or equivalent experience.
- Have excellent knowledge and good understanding of clinical trials and translational medicine in biomedical research.
- Minimum of 2-3 years proven experience working in teams managing clinical studies.
- Proven experience working with clinical biosample logistics and operations.
- Knowledge of GCP, GCLP and ICH guidelines, and animal welfare regulations (training can be done after recruitment).
- Excellent IT and analytical skills. Experience with sample management systems and procedures is a plus.
- Excellent written and interpersonal communication skills necessary to interface with outside vendors, consultants, and internal team members.
- Demonstrated ability to collaborate with a diverse group of scientists, clinicians, vendors labs, and a variety of internal and external stakeholders to support product development strategy.
- Fluent in English.
Debiopharm can offer you:
- An international and highly dynamic environment, with a long term vision
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.