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About the Role

Lead the operational strategy for central laboratory activities in global clinical trials, translating scientific intent into reliable data to advance studies and improve patient outcomes. Serve as the laboratory operations subject matter expert, providing end-to-end oversight from protocol development through study archiving. Drive cross-functional collaboration and continuous process improvement in line with clinical trial regulations and company standards.

Responsibilities

Define and lead the end-to-end operational strategy for central laboratory activities across assigned studies and programs.
Own central laboratory Scope of Work development and execution.
Serve as the operational point-of-contact between study teams, scientific functions, and central labs.
Coordinate sample flow from sites to central labs and onward to third-party labs.
Act as escalation point for laboratory data reconciliation.
Confirm analysis scope with science, statistics, and Data Management for Clinical Data Lock Readiness.
Lead central lab/third-party lab/biobank actions related to consent withdrawal.
Provide operational oversight of central lab vendors, including budget review and performance monitoring.
Ensure laboratory documents are complete, accurate, archived, and adhere to global clinical processes for inspection readiness.
Lead and facilitate laboratory-focused forums and contribute laboratory content to meetings.
Serve as therapy area laboratory expert to study teams.
Drive centralization and standardization of lab operational tasks, templates, guidance, and tools.
Develop and maintain laboratory operational plans, timelines, and risk registers.
Participate in lab-related global non-study initiatives.
Deliver targeted training and guidance on central lab processes to clinical teams.

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.
2+ years of project management experience.
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.
Demonstrated ability to influence without authority and coordinate complex workstreams.
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.
Advanced degree, Masters level education (or higher) (Desirable).
Project management certification (Desirable).
Proven project management experience on a global level (Desirable).
Experience in all phases of a clinical study lifecycle (Desirable).
Experience with central lab operations (Desirable).
Proficiency in Microsoft Project (Desirable).
Basic change management skills (Desirable).
Good intercultural awareness (Desirable).
Ability to prioritize and manage multiple tasks with conflicting deadlines (Desirable).
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities (Desirable).

Skills

Leadership
Cross-functional collaboration
Project management
Planning
Risk management
Timeline and budget oversight
Vendor coordination
Communication
Stakeholder management
Relationship-building
Negotiation
Conflict management
Organizational skills
Problem-solving
Attention to detail
Fluent verbal and written English
Microsoft Project proficiency (Desirable)
Basic change management (Desirable)
Intercultural awareness (Desirable)
Prioritization (Desirable)
Flexibility (Desirable)

Location

Hybrid
3 days in the office per week

Work Type

Hybrid

Experience Level

At least 5 years of relevant clinical experience
2+ years of project management experience

Education Level

Bachelor's degree, preferably in medical or biological sciences or clinical research discipline.
Master's level education (or higher) (Desirable).

Salary/Compensations

$137,937 USD to $206,906 USD (annual base pay)
Eligibility for short-term incentive bonuses
Eligibility for equity-based awards for salaried roles

Benefits

Qualified retirement programs
Paid time off (vacation, holiday, leaves)
Health coverage
Dental coverage
Vision coverage

About the Company

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company.
Focus on discovering, developing, and commercializing prescription medicines for serious diseases.
Dedicated to being a Great Place to Work, empowering employees to push scientific boundaries.
Committed to an inclusive and equitable environment where people belong.
Values kindness, ambition, smart risk-taking, and continuous learning.
Drives innovation through diverse workforce and breakthrough ideas.
Fosters a culture of lifelong learning, growth, and development.
Aims to help employees realize their full potential and make a difference in medicine, patients, and society.

Equal Opportunity

Mission to build an inclusive environment with equal employment opportunities for all applicants and employees.
Welcomes and considers applications from all qualified candidates, regardless of protected characteristics.
Provides accommodation for disabilities or special needs.
Inclusion & Diversity mission to create an inclusive and equitable environment where people belong.
Believes innovation requires breakthrough ideas from a diverse workforce.