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Biospecimen Operations Manager - Contract - Wilmington, DE

Help transform clinical samples into scientific insight as our next Biospecimen Operations Manager.

À±½·ÊÓƵ is seeking a Biospecimen Operations Manager to support translational medicine objectives within clinical study teams.

Primary Responsibilities:

The successful candidate is a detail-oriented professional who thrives in a collaborative environment and is committed to operational excellence. This role involves managing biospecimen collection and analysis processes, ensuring compliance with clinical protocols, and collaborating with cross-functional teams to deliver high-quality results.

Skills & Requirements:

• Background in science (e.g., BS, RN, Med Tech) with experience in clinical drug development, clinical trial execution, or central lab study setup.
• Familiarity with biomarkers, pharmacokinetics, immunogenicity sample activities, and informed consent language for human tissue specimens.
• Understanding of the drug development process and clinical lab/trial site operations.
• Experience working with Contract Research Organizations (CROs).
• Knowledge of ICH and GCP guidelines.
• Proficiency in Microsoft Office programs and electronic data/sample management systems.
• Strong attention to detail, record-keeping skills, and problem-solving abilities.
• Excellent teamwork, interpersonal, and communication skills.

The Biospecimen Operations Manager's responsibilities will be:

• Collaborate with clinical study teams to integrate translational medicine objectives into protocol development and execution.
• Support the tactical execution of biospecimen collection and analysis during clinical protocol development, study start-up, and amendments.
• Contribute to and review protocols, lab manuals, and clinical laboratory documents, ensuring effective communication across departments and external partners.
• Assist the Data Management team with eCRF setup, database build for sites, and sample tracking/reconciliation.
• Standardize nomenclature, pictograms, sample handling instructions, and resources across central labs to ensure consistency across studies.
• Coordinate with internal and external stakeholders to track and manage samples, projects, and deliverables.
• Support informed consent form tracking and clinical program sample storage using in-house and commercial systems.
• Participate in vendor meetings to stay updated on current and upcoming projects, technologies, and offerings.
• Independently address challenges, fostering collaboration and inclusivity.
• Prioritize workload effectively to meet the needs of multiple protocols and departmental objectives.
• Stay informed about local and international regulations related to the privacy of personal information associated with clinical samples.
• Contribute to process improvement initiatives to enhance operational efficiency.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.

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