Biospecimen Operations Manager

Title: Biospecimen Operations Manager

Location: Wilmington United States

Job Description:

category Laboratory & Sciences

70000 USD - 90000 USD/hour

Job Title: Biospecimen Operations ManagerJob Description

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.

Responsibilities

• 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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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 instructions across multiple studies.
• Demonstrated ability to manage multiple projects and prioritize tasks in a dynamic clinical development environment.
• Experience participating in vendor meetings and evaluating new technologies or vendor offerings related to biospecimen handling and analysis.
• Experience supporting process improvement initiatives to enhance biospecimen operations and overall study efficiency.

Work Environment

This role operates in a hybrid work environment, with three days onsite and two days remote each week. Onsite work typically takes place in a professional office and laboratory-support setting, involving close collaboration with translational medicine, clinical operations, data management, and central laboratory partners. The position relies heavily on the use of electronic data systems, controlled sample management systems, and standard office productivity tools such as Microsoft Office. The work involves regular virtual and in-person meetings with internal teams and external vendors, as well as coordination across multiple concurrent clinical studies. The environment emphasizes accuracy, regulatory compliance, and cross-functional teamwork in support of clinical research and biospecimen management.

Job Type & Location

This is a Contract position based out of Wilmington, DE.

Pay and Benefits

The pay range for this position is $70000.00 - $90000.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Wilmington,DE.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability. 

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.