REMOTE Biosample Operations Manager

Biosample Operations Manager

REMOTE

Contract- 6 month potential contract renewable

Hourly W2 contract (Health benefits available while on contract)-

Early phase oncology experience

Job Description

We are seeking a highly motivated Biosample Operations Manager with a passion for new cancer therapy development. This role involves providing leadership to Clinical Development Execution and / or the Study Management Team, as well as overseeing laboratory vendors for clinical programs. The successful candidate will represent Clinical Operations and collaborate with Biomarker Sciences, Pharmacology, Clinical Data Management, Medical Monitor, and other key functions to ensure the successful completion of all clinical activities and project deliverables. This position offers an opportunity to apply technical skills, learn new ones, and play a key role in clinical trial planning and execution.

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, to support clinical sample tracking, collection, and storage. Responsibilities include drafting and reviewing RFPs, vendor selection, defining scopes of work, vendor management, and contract management to support study objectives and goals.

Implement study-specific biosample analysis plans and data management or transfer agreements 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 study execution on the strategy.

Facilitate resolution of sample and data discrepancies.

Write or contribute to the 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, which may include optimizing laboratory manuals and contributing to the development of patient and site-friendly sample collection materials for investigators, site staff, vendor staff, and team members.

Proactively identify areas of best practice and process improvements. Participate in 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, including Microsoft Suite (Excel, Project), Smartsheet, Adobe, and other clinical systems such as CTMS and TMF.

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

Additional Skills & Qualifications

Early phase oncology trial management experience is preferred.

Work Environment

The work environment is fully remote, allowing for a flexible work-life balance. You will be part of a passionate and committed team working at the forefront of oncology medicine, where collaboration and teamwork are key to advancing science.

Job Type & Location

This is a Contract position based out of Dallas, TX.

Pay and Benefits

The pay range for this position is $65.00 - $85.00 / 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 Nov 28, 2025.

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.