̽»¨ºÏ¼¯

Biospecimen Operations Manager - Contract - Wilmington, DE

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

̽»¨ºÏ¼¯ 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.

̽»¨ºÏ¼¯ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽»¨ºÏ¼¯ is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - /privacy-policy