Associate Director, Specimen Management & Lab Start-Up, Remote
About the role
The Associate Director, Specimen Management & Lab Start-Up is responsible for leading and overseeing laboratory study start-up and specimen management activities across a portfolio of clinical trials. This role ensures the successful planning, implementation, and execution of laboratory-related operational requirements to support study initiation, specimen collection, processing, shipment, tracking, reconciliation, and issue resolution.
Responsibilities
Lead laboratory and specimen management activities during study start-up for assigned clinical trials or programs.
Review study protocols to assess specimen collection, processing, storage, shipment, and testing requirements.
Oversee development and review of laboratory manuals, specimen collection guidelines, requisition forms, and related study documents.
Capture and coordinate central laboratory, specialty laboratory, and provider set-up activities to ensure operational readiness prior to site activation.
Partner with study teams to align laboratory timelines with broader study start-up milestones.
Identify study risks related to specimen handling or lab operations and implement mitigation plans.
Oversee end-to-end specimen lifecycle management processes, including: collection requirements, processing workflows, packaging and shipment, chain of custody, sample tracking, reconciliation, discrepancy management.
Ensure specimen operations are executed in accordance with protocol, our expectations, and internal standards.
Monitor sample-related metrics, quality issues, and trends to drive timely issue resolution and performance improvement.
Provide escalation support for specimen-related operational issues that may impact sites, laboratories, or study timelines.
Manage relationships with central laboratories, specialty laboratories, courier/logistics providers, and kit providers.
Support provider selection, feasibility assessments, scope review, and operational planning.
Oversee provider performance against service level agreements (SLAs), turnaround times, quality expectations, and study deliverables.
Facilitate provider governance meetings, performance reviews, and issue escalation/resolution.
Ensure external partners are aligned with protocol-specific sample handling requirements and study timelines.
Collaborate closely with Clinical Operations, Biomarker Managers, Pharmacokinetics, Data Management, Regional teams, Quality, and other internal stakeholders to support seamless study execution.
Act as the subject matter expert for specimen management and lab start-up processes during study planning and execution.
Provide recommendations on protocol feasibility and operational design related to specimen collection and laboratory workflows.
Communicate study risks, readiness status, and key specimen management updates to internal and external stakeholders.
Ensure specimen management and lab start-up activities comply with: Good Clinical Practice (GCP), Applicable GxP requirements, IATA/DOT shipping regulations, internal SOPs and quality standards.
Maintain inspection readiness for laboratory and specimen-related processes.
Support deviation investigations, root cause analysis, corrective and preventive actions (CAPA), and quality improvement initiatives.
Promote consistent documentation practices and operational compliance across studies and teams.
Provide day-to-day leadership, coaching, and guidance to specialists, senior specialists, and/or managers supporting specimen management and lab start-up activities.
Aid in workload planning, prioritization, and resource coordination across assigned studies or programs.
Contribute to staff development, training, onboarding, and performance feedback.
Foster a collaborative, accountable, and continuous-improvement-focused team culture.
Evaluate existing specimen management and start-up processes to identify opportunities for improvement, standardization, and scalability.
Support implementation of new technologies, tools, and workflows to improve specimen visibility, tracking, and operational efficiency.
Develop and report key performance indicators (KPIs) related to study start-up readiness, sample quality, reconciliation, and provider performance.
Lead or contribute to strategic initiatives to improve site experience, data quality, and operational execution.
Qualifications
Bachelor’s degree required.
Minimum of 5 years in laboratory, biopharmaceutical and/or the supplier industry.
Proven experience in specimen management and lab start-up.
Strong interpersonal skills including cross-functional teamwork, and written and oral communication skills, negotiation skills, exceptional analytical skills, multi-cultural skills, high energy level, and a bias toward action.
Solid understanding of clinical development and operations best practices.
Microsoft office skilled (e.g., excel and power point).
Biorepository system background preferred.
Preferred Qualifications
Previous biorepository and/or specimen management experience.
Previous clinical trial management experience.
Previous experience in the supplier industry.
Previous experience in project management.
Previous experience in risk management.
Previous experience in schedule management.
Previous experience in stakeholder communications.
Previous experience in test lab management.
Skills
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Requirements
Equal Employment Opportunity Employer
Personal Rights Under the U.S. Equal Opportunity Employment laws
Salary Range
Requisition ID: R409417