Associate Director Study Management, Central Lab Operations

AstraZeneca•South San Francisco, CA

2d•$137,937 - $206,906•Hybrid

About The Position

In this role, you will lead the operational strategy for central laboratory activities across global trials, translating scientific intent into reliable, on-time data that informs trial decisions and ultimately improves patient outcomes. You will be the laboratory operations subject matter expert for the study team, orchestrating cross-functional delivery from protocol through close-out. Working closely with scientific leads, clinical operations, data management, supply chain and external laboratories, you will align kit design, logistics, testing workflows and data reconciliation to the needs of each study. The Associate Director, Study Management – Central Laboratory Operations (ADSM Central Lab) is a core member of the global study team and acts as the central laboratory operational subject matter expert (SME) and therapy area (TA) lab expert. This role provides end-to-end operational oversight of central laboratory activities from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, and study archiving. The ADSM Central Lab leads cross-functional collaboration across Translational Medicine, Precision Medicine, Bioanalytics, Clinical Development, Biosampling, Data Management, Site Management & Monitoring, R&D Supply Chain, Procurement, and external service providers (e.g., central labs and third-party labs), ensuring delivery to scope, quality, budget, and timelines. The role drives laboratory-related initiatives and workstreams, establishes standards, and continuously improves central lab processes in line with current clinical trial regulations (e.g., ICH GCP), AstraZeneca SOPs, policies, guidelines, and AZ values and behaviours. This role is a hybrid position and we require employees to work 3 days in the office per week.

Requirements

Minimum of bachelor's degree, preferably in medical or biological sciences or a discipline associated with clinical research.
At least 5 years of relevant clinical experience in the pharmaceutical industry, including 2+ years of project management experience; substantive.
Extensive knowledge of clinical research regulatory requirements and laboratory operations; excellent understanding of ICH/GCP, and study management processes.
Strong leadership and cross-functional collaboration skills with demonstrated ability to influence without authority and coordinate complex workstreams across scientific and operational functions.
Proven project management skills, including planning, risk management, timeline and budget oversight, and vendor coordination; proficiency with standard project tools and IT systems.
Excellent communication, stakeholder management, and relationship-building skills; strong negotiation and conflict management capabilities.
Strong organizational and problem-solving skills; ability to manage competing priorities and maintain attention to detail.
Fluent verbal and written English.

Nice To Haves

Advanced degree, Masters level education (or higher)
Project management certification
Proven project management experience on a global level
Experience in all phases of a clinical study lifecycle
Experience with central lab operations
Proficiency in Microsoft Project
Basic change management skills
Good intercultural awareness
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

Responsibilities

Define and lead the end-to-end operational strategy for central laboratory activities across assigned studies and programs, aligned to protocol, biosampling plans and scientific requirements, to deliver scope, quality, budget and timelines.
Own central laboratory Scope of Work development and execution, consolidating scientific input, coordinating reviews, managing comments, securing COL/budget alignment, ensuring execution and eTMF completeness.
Serve as the operational point-of-contact between study teams, scientific functions and central labs; drive timely kit design and supply, sampling instructions, shipping logistics and testing workflows that meet study needs.
Coordinate sample flow from sites to central labs and onward to third-party labs; manage country-specific biosampling requirements and restrictions; proactively identify and mitigate laboratory risks.
Act as escalation point for laboratory data reconciliation; share reconciliation logs and partner with CRAs and Data Management on issue resolution; advise on header file DTS questions.
Confirm analysis scope with science, statistics and Data Management; secure central lab timelines; ensure samples are shipped, received and tested to meet CDL needs; partner with GSAD and central labs to communicate DCO expectations.
Lead central lab/third-party lab/biobank actions related to consent withdrawal in VCV, reconcile completion of laboratory actions, and coordinate site actions with CRAs; review study-specific Patient Follow-Up and Consent Withdrawal Checklist templates.
Provide operational oversight of central lab vendors, including PO coordination where applicable, budget review, invoice reconciliation and performance monitoring; document CRO/central lab oversight per standards.
Ensure laboratory documents (SOWs, lab manuals, kit instructions, communications) are complete, accurate and archived in the eTMF; adhere to global clinical processes and Quality & Compliance manuals to maintain inspection readiness.
Lead and facilitate laboratory-focused forums and contribute laboratory content to Investigators’/Monitors’ Meetings; align stakeholders on biosampling priorities, timelines and operational decisions.
Serve as therapy area laboratory expert to study teams, providing guidance that links scientific objectives to operational execution.
Drive centralization and standardization of lab operational tasks, templates, guidance and tools; lead or contribute to continuous improvement and change projects; identify opportunities for automation and AI and implement where applicable.
Develop and maintain laboratory operational plans, timelines and risk registers; communicate lab updates and their impact on CSP, ICF, TMG and essential documents; support distribution of essential documents to co-development partners per agreements.
Participate in lab-related global non-study initiatives that uplift capabilities and standards across the portfolio.
Deliver targeted training and guidance on central lab processes to Study and Program Management and broader clinical teams; capture and share lessons learned and best practices.