Biosample Operations Manager

Actalent • South San Francisco, CA • 3h ago

Job Title: Biosample Operations Manager

Fully Remote PST Hours

Job Description

Seeking a highly motivated Biosample Operations Manager with a passion for new cancer therapy development. This role will be responsible for providing leadership to Clinical Development Execution and/or Study Management Team and oversight of laboratory vendors for clinical programs. As a Biosample Operations Manager, you will represent Clinical Operations and work directly with Biomarker Sciences, Pharmacology, Clinical Data Management, Medical Monitor, and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills, learn new skills and play a key role in clinical trial planning and execution. As a member of our dynamic group, you will help to grow the pipeline.

Responsibilities

Develop and maintain effective, collaborative relationships with internal study execution/management teams, CROs, laboratory service providers, and other key stakeholders.

Manage key service providers, including Central and other laboratories as needed, and CROs to support clinical sample tracking and collection, and sample storage including drafting and reviewing RFPs, vendor selection, defining scopes of work, vendor management, and contract management in support of study objectives and goals.

Implement study-specific biosample analysis plan and data management or transfer agreement for each study.

Lead the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data reconciliation and transfer, to final sample disposition, in accordance with study protocol and informed consent.

Collaborate with biomarker sciences and pharmacology to oversee all study biosample operational activities and regularly report on status, including Key Performance Indicators.

Support biomarker sciences and clinical development on Companion Diagnostics strategy development and lead the study execution on the strategy.

Facilitate resolution of sample and data discrepancies.

Write or contribute to preparation of clinical documents, such as protocols, informed consent forms, case report forms, laboratory specifications and manuals.

Provide education and training for sample collection, handling, and shipment, including optimization of laboratory manuals and contributing to the development of patient and site-friendly sample collection materials, to investigators and site staff, vendor staff and team members.

Proactively identify areas of best practice and process improvements. Participate and/or lead Biosample Operations initiatives.

Essential Skills

Bachelor's degree in life sciences or related discipline with 8-10 years of experience in clinical and drug development.

Clinical or biological laboratory experience with involvement in the processing and/or analysis of biological samples.

Extensive clinical trial management experience from study start-up through to close-out, particularly in oncology and/or precision medicine early drug development.

Familiarity with oncology laboratory terminologies as well as genomic biomarker and pharmacodynamic endpoints from tissue and blood samples.

Thorough knowledge of FDA and ICH/GCP regulations and guidelines.

Self-motivated and takes pride in work.

Results-oriented team player; enjoys working collaboratively with colleagues and building positive relationships.

Detail-oriented and creative thinker with a passion for process optimization.

Excellent organizational and communication skills.

Proficient in computer software, e.g., Microsoft suite including MS Excel and MS Project, Smartsheet, Adobe, and other clinical systems such as CTMS, TMF.

Ability to analyze and triage problems, prioritize accordingly, and propose solutions.

Additional Skills & Qualifications

Early phase oncology trial management experience preferred.

Work Environment

The position is fully remote, following Pacific Standard Time (PST).

Job Type & Location

This is a Contract position based out of South San Francisco, CA.

Pay and Benefits

The pay range for this position is $80.00 - $100.00/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 fully remote position.

Application Deadline

This position is anticipated to close on Feb 24, 2026.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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