Global Study Manager

Introduction to role
The Global Study Manager (GSM) is a pivotal role within Development Operations, integral to the global study team. You will support the delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, and development of Clinical Study Report (CSR) to study archiving. Collaborating with internal and external partners, you will ensure the successful execution of delegated aspects of clinical studies in accordance with the Study Lead. You will drive scope discussions, oversee vendor activities, provide status updates, and develop, review, and approve study documents. Studies may span various therapeutic areas and all phases (I-IV), including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, and Early Access Programs.

Accountabilities
- Strategize, set up, and oversee key vendors to support study deliverables according to agreed timelines, budget, and quality standards.
- Ensure efficient study delivery by collaborating with Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including CROs.
- Contribute to planning and conducting internal and external meetings (e.g., Investigators’/Monitors’ meeting).
- Support the Study Lead with budget management and external service provider invoice reconciliation.
- Develop and maintain relevant study documents/plans.
- Perform Study Lead activities for less-complex studies.
- Delegate and oversee team member responsibilities.
- Conduct lessons learned exercises to document continuous improvement processes.
- Participate in or lead departmental initiatives or SME functions.
- Coordinate and report start-up and recruitment activities at the study level across all countries.
- Monitor and oversee sites globally on assigned studies.
- Aggregate and communicate deliverables for assigned studies globally to the CTT and country teams.
- Resource and train CRAs for assigned studies.
- Develop and review applicable study documents including training materials and clinical monitoring plans.
- Coordinate country team activities related to key study events.
- Oversee country activities related to site close-out and post-trial access post final database lock.
- Support other study and functional activities as assigned.

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 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.
- Ability to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience
- PMP certification desirable.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit of a leading biotech while meeting the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed for skill enhancement and fostering a deep understanding of our patient's journeys. Make an impact by driving change with integrity in a culture that celebrates diversity, innovation, and connection to patient experiences.

Ready to make a difference? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.