Global Study Manager

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

This is what you will do:

The Global Study Manager (GSM) is a role within Development Operations and is a member of the global study team supporting delivery of clinical studies from Clinical Study Protocol (CSP) development through study setup maintenance closeout development of Clinical Study Report (CSR) to study archiving. The GSM works with internal and external partners to deliver delegated aspects of the clinical study in accordance with the Study Lead . The GSM will drive the scope of work discussions and oversee delivery of daytoday activities delegated to the vendors. The GSM will provide status updates and performance metrics and develop review and approve related study documents.
Studies may be across various therapeutic areas and all phases (IIV including Late Phase NonInterventional Post Authorization Safety Studies Registries Early Access Programs etc..

You will be responsible for:

• The strategy set up and oversight of key vendors in support of study deliverables according to agreed timelines budget and quality standards while ensuring that the appropriate level of oversight of the vendors is maintained and documented through the life cycle of the study.

• Data Management Procurement Regulatory Patient Safety and Quality Assurance and external functions including the CROs and other external service providers to ensure an efficient study delivery to time costs and quality objectives.

• Contributes to the planning and conduct of internal and external meetings meeting).

• Supports the Study Lead with budget management such as external service provider invoice reconciliation. As well as developing and maintaining relevant study documents/plans (e.g. global study management plan and its relevant components etc..

• Perform Study Lead activities for lesscomplex studies (e.g. small studies studies in conduct or closeout OLE etc..

• Delegate and oversee team member responsibilities.

• Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices.

• Participate in and/or lead departmental initiatives and/or SME function.

• Coordination and reporting of startup and recruitment activities at the study level across all countries.

• Monitoring and site oversight globally on assigned study(ies) representing the monitoring function on the CTT.

• Aggregation and communication of deliverables for assigned study(ies) globally to the CTT and country teams respectively.

• Resourcing (with assistance of country teams) and studyrelated training of CRAs for assigned study(ies).

• Developing and/or reviewing applicable study documents including but not limited to training materials clinical monitoring and oversight plans.

• Coordinating country teams activities related to key study events such as protocol amendments interim database locks and Investigator Meetings.

• Post final database lock overseeing country activities related to site close out activities and posttrial access as required.

• Support other study and functional activities as assigned.

You will need to have:

• 5 years of clinical research experience 3 of which in a leading role accountable for the planning and of global clinical trials.

• Bachelors 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 officebased 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 nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• PMP certification

At Alexion you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients lives.

Ready to lead and inspire Apply now and take the first step towards a fulfilling career at Alexion AstraZeneca Rare Disease.

#LIHybrid

Date Posted

Closing Date

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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.