Biological Sample Handling Lead
Vor 4 Tagen
About Us
Debiopharm International SA is a Swiss-based biopharmaceutical company focused on developing innovative therapies for oncology and infectious diseases.
Our unique business model enables us to act as a bridge between cutting-edge discovery products and patient access in international markets.
We are committed to improving patient outcomes and quality of life through our research and development efforts.
Job Role
The Biosample Management Lead will be responsible for overseeing the entire lifecycle of biological samples in clinical trials, from initial feasibility to long-term storage and preclinical studies.
This role requires strong expertise in sample logistics, central lab operations, and global regulatory frameworks to ensure compliance with ethical, regulatory, and analytical standards.
- Develop and implement effective biosample handling strategies that align with study protocols, regulatory requirements, and Standard Operating Procedures (SOPs).
- Collaborate with cross-functional teams to optimize biosample workflows and ensure seamless integration with clinical trials.
- Maintain accurate records of biosample collection, storage, logistics, and analysis while addressing deviations and implementing corrective actions.
- Lead the development of biosample-related trial documents, including Biosample Management Plans, Central Laboratory Manuals, and Data Transfer Specifications.
- Oversee the preparation and delivery of Central Laboratory sample kits to clinical sites, as well as clinical sample shipments to specialty labs.
- Manage clinical biosample and preclinical specimens retention and destruction in accordance with patient consent, study protocols, and regulatory guidelines.
- Serve as a subject matter expert, driving innovation, process improvements, and training initiatives in biosample management.
Key Qualifications
- Advanced degree in Life Sciences or Healthcare with a minimum of 5 years of experience in clinical biosample management.
- Proven expertise in sample logistics, central lab operations, and global regulatory frameworks.
- Strong understanding of ethical and legal requirements for handling human and non-clinical biospecimens.
- Familiarity with ICH GCP/GLP/IVDR and country-specific accreditations/certifications for Central Laboratories.
- Excellent communication and stakeholder collaboration skills.
- Ability to work effectively in a fast-paced, dynamic environment.
About Our Work Environment
We offer a dynamic and inclusive work environment that fosters collaboration and innovation.
As a member of our team, you will have the opportunity to contribute to the development of cutting-edge treatments for patients worldwide.
Join us in our mission to improve patient outcomes and quality of life through our commitment to excellence in research and development.
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