Are you ready to orchestrate global clinical studies that deliver life-changing medicines to people with rare and devastating diseases? Step into a role where your leadership turns complex study plans into real-world outcomes for patients, from protocol development through study close-out and archiving.
As a key member of a global study team, you will unite internal experts and external partners across multiple geographies and phases (I–IV, including non-interventional, post-authorization safety studies, registries, and early access programs). Your decisions will drive timelines, cost, and quality—accelerating access while safeguarding scientific and operational excellence.
You will translate strategy into action—leading vendor oversight, aligning country teams, and ensuring first-time-right delivery. How will you bring clarity, pace, and confidence to a global program where every month matters for patients and clinicians?
Accountabilities:
Vendor Strategy and Oversight: Define scope, negotiate expectations, and manage performance of CROs and service providers to timeline, budget, and quality; maintain documented oversight throughout the study lifecycle. - End-to-End Study Delivery: Coordinate delivery from Clinical Study Protocol through set-up, maintenance, database locks, CSR development, and archiving, ensuring alignment with the Study Lead and governance standards.
Cross-Functional Integration: Partner with Data Management, Procurement, Regulatory, Patient Safety, Quality Assurance, and country teams to remove barriers and optimize study execution.
Meeting Leadership and Engagement: Plan and contribute to internal and external forums, including Investigators’ and Monitors’ meetings, to drive clarity and commitment on milestones.
Budget Stewardship: Support the Study Lead with budget oversight and invoice reconciliation for external providers to maintain financial accuracy and predictability.
Study Documentation and Planning: Develop and maintain global study management plans and related documents that set clear, actionable expectations across teams and vendors.
Lead for Less-Complex Studies: Act as Study Lead for smaller, in-conduct, or close-out studies, including open-label extensions, ensuring continuity and quality.
Team Leadership and Delegation: Delegate and oversee responsibilities across the study team to build capability, strengthen accountability, and sustain delivery pace.
Continuous Improvement: Conduct lessons-learned exercises and embed best practices to raise standards across current and future programs.
Departmental and SME Contributions: Participate in and/or lead departmental initiatives; serve as a subject matter expert to influence ways of working and tools.
Start-Up and Recruitment Acceleration: Coordinate and report start-up and enrollment activities at the study level across countries; anticipate risks and drive mitigations.
Global Monitoring and Site Oversight: Represent the monitoring function on the core team; ensure site performance and compliance through proactive oversight.
Delivery Reporting and Communication: Aggregate and communicate global study deliverables to the core team and country teams, providing clear, timely status and risk signals.
CRA Resourcing and Training: Partner with country teams to resource CRAs and deliver study-specific training, enabling consistent quality at the site level.
Study Materials and Oversight Plans: Develop and/or review training materials, clinical monitoring plans, and oversight plans that translate protocol intent into operational control.
Country Operations for Key Milestones: Coordinate country-level execution for protocol amendments, interim database locks, and Investigator Meetings to keep the global plan on track.
Close-Out and Post-Trial Access: Following final database lock, oversee site close-out and post-trial access activities as required to ensure compliant completion.
Additional Contributions: Support other study and functional activities as assigned to meet portfolio needs.
Essential Skills/Experience:
>5 years of clinical research experience, 3 of which in a leading role accountable for the planning and execution of global clinical trials.
Bachelor’s degree or equivalent, in one of the disciplines related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.
Excellent organizational communication and time management skills.
Highly proactive and willing to take initiative. • Strong relationship building skills.
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Desirable Skills/Experience:
Why AstraZeneca: Here, proximity to patients shapes every decision and keeps teams tightly connected to the meaning of their work. You will join an agile, collaborative environment that blends the inventive spirit of a biotech with the scale and scientific depth of a global biopharma. Expect to work shoulder-to-shoulder with unexpected combinations of experts—clinical, safety, data, and country operations—in the same room unleashing bold thinking. We value kindness alongside ambition, encourage you to speak up, and invest in your development so you can grow at pace while advancing programs that matter for people with urgent, underserved needs.
Call to Action: If you are ready to lead global studies with precision and purpose—and to and step forward.
Date Posted
04-jun-2026
Closing Date
24-jun-2026
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.
