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Director Biospecimen Jobs (NOW HIRING)

University of Utah

Bioinformatics Management

Campus, IL · Hybrid

$110K - $122K/yr

Provide direct supervision, day-to-day work direction, mentorship, and performance evaluation for the research navigation team, including the BMIC Data Navigator and BMIC Biospecimen Navigator.

Vanderbilt Health

Manager, Laboratory

Nashville, TN · On-site

Direct experience working within a human tissue biorepository or biospecimen-focused program. * Strong background in cancer biology or translational research environments. * Demonstrated success ...

Vanderbilt Health

Manager, Laboratory

Nashville, TN · On-site

Direct experience working within a human tissue biorepository or biospecimen-focused program. * Strong background in cancer biology or translational research environments. * Demonstrated success ...

NYULMC

Director, Business Operations

New York, NY · On-site

Reporting to the Senior Director of Business Operations, Regulatory Affairs, and the Center for Biospecimen Research and Development, the Director of Business Operations leads performance management ...

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Director Biospecimen information

What does a director biospecimen do?

A Director of Biospecimen oversees the collection, processing, storage, and distribution of biological samples used in research or clinical trials. They ensure that all biospecimen handling complies with regulatory standards and ethical guidelines. Additionally, they manage teams, develop protocols, and collaborate with researchers to support scientific studies. Their role is critical in maintaining the integrity and quality of samples, which directly impacts the reliability of research results.

What are the key skills and qualifications needed to thrive as a director biospecimen?

To thrive as a Director of Biospecimen, you need expertise in biospecimen management, laboratory operations, and regulatory compliance, typically supported by an advanced degree in life sciences or a related field. Familiarity with Laboratory Information Management Systems (LIMS), quality assurance protocols, and certifications like CAP or CLIA accreditation are often required. Strong leadership, organizational, and communication skills help manage teams, ensure protocol adherence, and foster collaboration with research stakeholders. These skills are vital for maintaining specimen integrity, supporting research objectives, and ensuring compliance with ethical and regulatory standards.

What are some common challenges faced by a director biospecimen, and how can they be addressed?

A Director of Biospecimen Management often faces challenges such as ensuring regulatory compliance, maintaining specimen integrity throughout the lifecycle, and coordinating among cross-functional teams like clinical operations, data management, and laboratory staff. Addressing these challenges typically requires implementing robust standard operating procedures, investing in ongoing staff training, and leveraging technology for tracking and documentation. Effective communication skills are also crucial, as the director must align project timelines and priorities across multiple stakeholders while upholding quality standards.

What is the difference between Director Biospecimen vs Laboratory Manager?

AspectDirector BiospecimenLaboratory Manager
CredentialsTypically requires advanced degrees (e.g., PhD, MD) and specialized biospecimen handling certificationsUsually requires a bachelor's or master's degree in life sciences or related field, with laboratory management certifications
Work EnvironmentResearch institutions, biobanks, pharmaceutical companies focusing on biospecimen collection and storageClinical or research laboratories overseeing daily lab operations and staff management
Employer & IndustryBiotech, pharmaceutical, academic research institutionsHospitals, clinical labs, research organizations

The main difference is that the Director Biospecimen focuses on overseeing biospecimen collection, storage, and quality in research settings, often requiring advanced scientific credentials. In contrast, the Laboratory Manager manages daily lab operations, staff, and compliance within a broader range of laboratory types. Both roles are essential in research and clinical environments but differ in scope and specialization.

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Director Biospecimen jobs near you
Infographic showing various Director Biospecimen job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, 1% Temporary, and 1% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

Manager, Clinical Operations

Meridian Bioscience, Inc.

Cincinnati, OH • On-site

Other

Re-posted 17 days ago

Job description

About Meridian
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.
Job Summary
The Manager, Clinical Operations is a seasoned professional with wide-ranging experience and a thorough understanding of clinical study management, biospecimen acquisition, FDA and ICH regulations and Good Clinical Practices (GCP). The candidate must be self-motivated, able to work and lead in a remote team environment and be able to establish strong, positive relationships with both internal departments, external clinical study sites and biospecimen vendors.
The successful candidate contributes to the development of Clinical Affairs processes and procedures at the project and company levels pertaining to Clinical Operations involvement in our clinical studies. The Manager, Clinical Operations will provide leadership and career development, mentoring and training for CRA, biorepository and clinical trial logistics staff as well as is responsible for Clinical Operations staff resourcing.
Key Duties
Tasks/Duties/Responsibilities:
  • Manage and facilitate the personal development of CRAs, including fostering career growth, and providing relevant company-specific, ethical, and regulatory trainings. Serves as a mentor and guide to junior employees. In addition, oversee the personal development of clinical trial logistics and biorepository personnel.
  • Partner with the Clinical Affairs Director to create and implement the strategic vision for the Clinical Operations team to ensure the high-quality end-to-end management of clinical trials, clinical trial logistics and internal/external biospecimen acquisition.
  • Lead Clinical Operations level initiatives for the development, maintenance and implementation of processes, tools, templates and plans.
  • Regularly monitor the overall health of the clinical studies from the study initiation to closure including regular evaluation of key metrics (enrollment, site activation), monitoring and escalation of project risks and mitigation plans when appropriate.
  • Lead and prepare the content for internal meetings with leadership, internal cross functional teams and external collaborators.
  • Functions as a working manager and takes on CRA responsibilities, as needed
  • Oversee CRAs during site visits (site initiation visit, interim monitoring visits and close-out visits), as needed.
  • Oversee the clinical operations aspects of timely data monitoring and partner with Clinical Affairs team leaders and study sites regarding generation and reconciliation of queries to ensure business timelines are met.
  • Direct the creation and collection of required study documents both internally and with the investigational study sites.
  • Responsible for all aspects of the biospecimen acquisition program, including forecasting and managing resources, timelines and budgets for external and internal biospecimen acquisition.
  • Implement strategies and best practices for the Clinical Operations team to build and maintain relationships with investigational study sites and vendors.
  • Responsible for resource allocation for the Clinical Operations team for assigned projects.
  • Travel: 30%
  • Other duties as assigned.

Qualifications
  • B.S. in Biological/Health Sciences or related Scientific fields; master's degree preferred
  • Certificate of completion from a Clinical Research Associate program is preferred
  • Minimum of 5 years of experience mentoring, managing, and leading a team
  • Minimum of 5 years experience as a CRA and/or Lead CRA
  • Minimum of 1-2 years experience with managing and/or working in clinical trial logistics and/or biorepository operations.
  • Experience with internal sample collection is preferred.
  • Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry as related to infectious diseases.
  • Thorough knowledge of FDA, ICH and GCP guidelines
  • Strong knowledge and experience with TMF/eTMF, EDC systems and CTMS preferred.
  • Be an initiative-taker, detail oriented, organized, and able to prioritize and balance workloads to meet strict critical deadlines along with performing under pressure in a fast- paced environment.
  • Highly motivated, readily adapts to changing priorities.
  • Excellent organizational skills with high attention to detail is required.
  • Able to work successfully under tight timelines.
  • Ability to manage, prioritize, and routinely report progress on multiple projects to cross functional teams and Clinical Management.
  • Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.

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