Manager, Clinical Lab Management

Position Description

Manager, Clinical Lab Management

Location

Remote

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Essential Duties & Responsibilities

Lead central laboratory operations for assigned clinical studies of moderate to high complexity, ensuring sample integrity, regulatory compliance, and on-time delivery of data.

Partner with Clinical Business Outsourcing to execute central lab contracts; review and finalize central lab Statements of Work (SOWs) and coordinate cross-functional stakeholder review.

Identify stakeholders for issues impacting clinical samples and escalate appropriately to ensure timely resolution.

Serve as the primary point of contact for CROs and clinical sites regarding sample collection, handling, shipment, and processing.

Support vendor selection, qualification, and management activities for central and specialty testing laboratories.

Coordinate with business partners and stakeholders to design and document sample flow for each study.

Author, review, and maintain the Clinical Sample Management Plan, ensuring accuracy, completeness, and alignment with the protocol.

Conduct clinical laboratory training for CRAs, clinical site personnel, and internal team members.

Utilize tracking systems to monitor progress, report status, and document issues and resolutions.

Lead study team and vendor meetings related to biosample management, ensuring requirements are clearly defined and met.

Identify and allocate Biosample Management resources required to support assigned studies.

Mentor and provide guidance to junior team members; develop and administer schedules and performance expectations and may hold budget responsibility.

Apply sound judgment within established practices and policies to evaluate complex situations and select appropriate methods and techniques for resolution.

Communicate effectively and professionally with internal and external partners, providing concise updates on progress, risks, and issues.

Work effectively in a dynamic, cross-functional operational environment and perform other related responsibilities as needed to support program objectives.

Qualifications & Experience

3–5+ years of experience in clinical research, biotechnology, pharmaceutical, or CRO environments, with at least 2 years of direct experience overseeing central laboratory activities for clinical studies.

Hands-on experience serving as the primary point of contact for central laboratory vendors, coordinating sample management activities, issue resolution, and day-to-day operational oversight.

Experience supporting clinical biosample management activities, including sample collection, processing, shipment, tracking, and reconciliation across multiple stakeholders.

Familiarity with the processes, capabilities, and restrictions of central laboratory vendors.

Oncology experience is beneficial but not required; candidates with strong clinical sample management experience across any therapeutic area will be considered.

Demonstrated ability to manage multiple priorities, troubleshoot operational issues, and drive resolution across internal and external partners.

Strong organizational, communication, and project coordination skills, with the ability to work effectively across Clinical Operations, Data Management, CROs, and laboratory vendors.

Working knowledge of ICH, GCP, and applicable GxP guidelines.

Strong written and verbal communication skills, with the ability to influence and align cross-functional stakeholders.

Self-starter and team player with strong interpersonal skills.

Education

Additional Information

Health Insurance (Medical/Dental/Vision)

Disability Insurance

Holiday Pay

Paid Time Off (PTO)

401(k) Match

Employee Stock Purchase Plan

Wellness Programs

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