Biological Sample Management Associate

Job Summary:

• We are seeking a Biological Sample Management Associate to join our Translational Medicine team.
• This role focuses on biospecimen sample management across multiple clinical trials and programs, ensuring accurate tracking, processing, and delivery of biological samples for pharmacokinetic, pharmacodynamic, safety, and exploratory analyses.
• The individual will report to Associate Director of Project Management in Translational Medicine and collaborate closely with Clinical Operations, Biometrics, and Data Management teams.

Key Responsibilities:

• Primary focus on biological sample management for several clinical trials within and across development programs.
• Track and reconcile sample collection, processing, and shipment activities; resolve sample-related issues in collaboration with Clinical Operations.
• Maintain and update laboratory processing instructions and ensure consistency across programs.
• Navigate central laboratory sample management systems and Client’s Clinical Pharmacology Laboratory Information Management System (CPLIMS) to generate inventory reports and manage sample orders.
• Place sample requests in compliance with protocol and informed consent requirements, including optional biomarker analyses and subject consent tracking.
• Troubleshoot discrepancies in sample requests and coordinate resolution with internal teams and external specialty vendors.
• Support development and review of biomarker-related content in protocols, informed consent forms, and laboratory manuals.
• Assist with vendor management activities such as RFPs, budget reviews, and Product of work for laboratory services.
• Collaborate on timelines for sample analysis and data transfer to meet program deliverables.
• Perform quality control checks on laboratory data prior to analysis and assist with ad hoc sample analysis requests.
• Provide input into protocol deviation lists related to biomarker/sample handling.
• Address site and IRB/EC/IBC questions regarding sample management.
• Attend study team meetings and contribute to sample-related discussions.
• Light travel (approx. 10%) as needed.

Requirements:

• Bachelor’s degree in biological sciences (preferred).
• 2–3 years of experience in biological sample management within clinical research or equivalent.
• Strong understanding of sample collection, processing protocols, and shipping conditions.
• Familiarity with Laboratory Information Management Systems (LIMS) and central lab systems (e.g., LabLink).
• Excellent organizational skills with ability to multitask and prioritize effectively.
• Detail-oriented, self-motivated, and able to work cross-functionally.
• Proficient in Microsoft Office and Excel.