Job Description:
Biosample Management Specialist
We are looking for a Biosample Management Specialist to oversee the end-to-end management of biological samples in clinical trials. This role ensures compliance with ethical, regulatory, and analytical standards while collaborating with cross-functional teams to optimize biosample workflows.
Your Key Responsibilities:
* Design and Implement Biosample Handling Strategies: Develop and implement strategies for biosample handling, ensuring alignment with study protocols, regulatory requirements, and SOPs.
* Manage Central Laboratories: Oversee the selection, qualification, and management of Central Laboratories, ensuring compliance with ICH GCP / GLP / IVDR and country-specific regulations, working in close collaboration with Clinical Trial teams and Translational Medicine.
* Ensure Proper Biosample Collection and Storage: Ensure proper biosample collection, storage, logistics, and analysis while addressing deviations and implementing corrective actions.
* Develop Biosample-Related Trial Documents: Lead the development of biosample-related trial documents, including Biosample Management Plans, Central Laboratory Manuals, and Data Transfer Specifications.
* Oversee Sample Kit Preparation and Delivery: Oversee Central Laboratory sample kits preparation and delivery to clinical sites, clinical sample shipments to specialty labs, ensuring timely delivery while maintaining chain-of-custody integrity.
* Manage Biosample Retention and Destruction: Manage clinical biosample and preclinical specimens retention and destruction in compliance with patient consent, study protocols, and regulatory guidelines.
* Support Audits and Inspections: Support audits and inspections by preparing documentation, addressing findings, and ensuring biosample processes meet compliance standards.
* Drive Innovation and Process Improvements: Act as a subject matter expert, driving innovation, process improvements, and training initiatives in biosample management.
About You:
* Degree in Life Sciences or Healthcare: A degree in Life Sciences or Healthcare with 5+ years of experience in clinical biosample management (end-to-end) at a sponsor.
* Strong Expertise in Sample Logistics: Strong expertise in sample logistics, central lab operations, and global regulatory frameworks.
* Understanding of Ethical and Legal Requirements: Understanding of ethical and legal requirements for handling human and non-clinical biospecimens.
* Knowledge of Regulatory Frameworks: Demonstrated knowledge of ICH GCP / GLP / IVDR and country-specific accreditations / certifications for Central Laboratories.
* Proficiency in Stakeholder Collaboration: Proficiency in stakeholder collaboration, problem-solving, and regulatory compliance.
* Excellent Communication Skills: Excellent organizational, communication, and time management skills.
* Language Skills: Excellent communication in English; French is an asset.
Debiopharm is proud to be an Equal-Pay certified company, ensuring equal opportunities for all our employees.