Associate Director, Specimen Management & Lab Start-Up, Remote

** Job Description*
* ** Position Summary*
* ** 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.*
* ** The Associate Director serves as a key cross-functional leader, partnering with Clinical Operations, Project Management, Data Management, Quality, Translational Medicine, Procurement, and external laboratories and logistics providers to ensure laboratory readiness and compliant specimen lifecycle management. This role provides strategic and operational oversight to support on-time study start-up, high-quality sample handling, and efficient study execution.*
* ** The ideal candidate brings strong expertise in clinical trial sample operations, lab start-up, provider oversight, global study support, and process improvement within a regulated environment.*
* ** Key Responsibilities*
* ** Study Start-Up Leadership*
* -       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.

-       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.

** Specimen Management Oversight*
* -       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.

** Provider and Laboratory Management*
* -       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.

** Cross-Functional Collaboration*
* -       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.

** Quality and Compliance*
* -       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.

** Team Leadership and Mentorship*
* -       Provide day-to-day leadership, coaching, and guidance to specialists, senior specialists, and/or managers supporting specimen management and lab start-up activities.

-       Assist with 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.

** Process Improvement and…