The Biospecimen Operations Manager plays a pivotal role in integrating translational medicine objectives into clinical studies and ensuring the smooth execution of biospecimen-related activities throughout the drug development lifecycle. This position bridges scientific, operational, and data management functions to support high-quality biospecimen collection, handling, tracking, and analysis in alignment with clinical protocols, regulatory standards, and study timelines.

• Play a key role in aligning translational medicine objectives with clinical study teams during protocol development and execution.
• Serve as an active member of the Translational Medicine clinical study start team and support the tactical execution of biospecimen collection and analysis during protocol development, study start-up, and amendments.
• Contribute to and review clinical protocols, laboratory manuals, and clinical laboratory documents to ensure accurate and consistent biospecimen requirements and procedures.
• Communicate biospecimen-related information clearly and promptly to internal departments and, when applicable, to contract research organizations and central laboratories.
• Participate in program meetings with central laboratories, clinical teams, operations, and data management to align timelines, expectations, and deliverables.
• Contribute to activities with the Data Management team, including study set-up, database build for sites, and processes for sample tracking and reconciliation.
• Participate in efforts to standardize nomenclature, pictograms, sample handling instructions, and resources for central laboratories to ensure consistency across studies.
• Coordinate with colleagues within the Translational Medicine group and with external stakeholders to track and manage biospecimen samples, projects, and deliverables.
• Support the development and coordination of processes for informed consent form tracking and clinical program sample storage and tracking using in-house and commercial systems.
• Participate in vendor meetings to stay informed about current and upcoming projects, innovative technologies, and vendor capabilities related to biospecimen management.
• Independently identify and resolve operational issues related to biospecimen activities, engaging internal and external stakeholders as needed while maintaining a collaborative approach.
• Prioritize workload effectively in response to the needs of multiple clinical protocols and departmental objectives.
• Maintain up-to-date awareness of local and international regulations related to the protection of personal information associated with clinical samples and ensure practices align with these requirements.
• Contribute to process improvement initiatives and help plan and implement procedures and systems that enhance operational efficiency in biospecimen management.
• Ensure accurate, detailed, and timely documentation and record keeping for all biospecimen-related activities, including tracking and resolution of issues.

• Scientific background such as a BS, RN, or Medical Technologist qualification.
• Minimum of 2 years’ experience in clinical drug development, clinical trial execution, or central laboratory study setup.
• Exposure to biomarker, pharmacokinetics, or immunogenicity sample activities, including sample collection procedures and logistics considerations.
• Experience with informed consent language specific to the handling of human tissue specimens.
• Understanding of the drug development process and familiarity with clinical laboratories and clinical trial sites.
• Experience working with contract research organizations (CROs).
• Demonstrated knowledge of International Council for Harmonisation (ICH) guidelines and Good Clinical Practice (GCP).
• Advanced skills in Microsoft Office applications.
• Good working knowledge of electronic data systems and controlled sample management systems.
• Strong attention to detail and precise record keeping skills, including the ability to track and resolve issues effectively.
• Proven ability to work collaboratively within cross-functional teams.
• Strong interpersonal, written, and verbal communication skills.

• Bench scientist background or laboratory experience, such as ASCP-certified laboratory technologist experience, transitioning into operations.
• Clinical operations or central laboratory experience supporting clinical studies.
• Experience contributing to standardization initiatives for biospecimen nomenclature, pictograms, and handling in