临床实验室管理经理

Position Summary
The Manager, Clinical Lab Management serves as the operational point of contact and functional lead for all activities related to central laboratory vendor oversight and clinical sample management. This role ensures the timely delivery of high-quality biological samples used to evaluate drug efficacy and is an integral member of the study team across study start-up, conduct, and close-out. The Manager ensures compliance with regulatory documentation and reporting requirements, develops operational procedures and plans, and may participate in vendor negotiations, product and software evaluations, implementations, and ongoing management. The role may support both clinical and discovery samples and directly contributes to the company’s research and development efforts to deliver high-value therapeutics that address unmet medical needs.
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
Bachelor’s degree or equivalent experience required; advanced degree is a plus.
Additional Information
Nektar currently anticipates the base salary for the Manager, Clinical Data Management to range from $150,000 to $185,000 for candidates in the Bay Area and will depend, in part, on successful candidate's location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company's discretion on an individual basis.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical/Dental/Vision)

• Disability Insurance

• Holiday Pay

• Paid Time Off (PTO)

• 401(k) Match

• Employee Stock Purchase Plan

• Wellness Programs

• Parental Leave Benefits (in accordance with the terms of applicable plans)

For general information on company benefits, please go to
Originally posted on Himalayas