Global Study Manager

Global Study Manager

Location: Mississauga ON (hybrid 3x a week)

When we put unexpected teams in the same room we unleash bold thinking with the power to encourage life-changing -person 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 outstanding and ambitious world.

Introduction to the role

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 set-up maintenance close-out 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 day-to-day 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 (I-IV including Late Phase Non-Interventional Post Authorization Safety Studies Registries Early Access Programs etc.).

What youll do:

• 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 (e.g. Investigators/Monitors meeting).
• Supports the Study Lead with budget management such as external service provider invoice reconciliation.
• Supports the Study Lead (GSAD GSD) with developing and maintaining relevant study documents/plans (e.g. global study management plan and its relevant components etc.).
• Perform Study Lead activities for less-complex studies (e.g. small studies studies in conduct or close-out OLE etc.).
• Delegate and oversee team member responsibilities.
• Conduct lessons learned exercise to help document continuous improvement process and sharing of guidelines.
• Participate in and/or lead departmental initiatives and/or SME function.
• Coordination and reporting of start-up 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 study-related 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 post-trial access as required.
• Support other study and functional activities as assigned.

Requirements:

• 5 years of clinical research experience 3 of which in a leading role accountable for the planning and execution of global clinical trials.
• Bachelors degree or equivalent in one of the fields related to clinical practice/health care life sciences or drug development or commensurate work experience.
• Pharmaceutical industry experience required.
• 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:

• PMP certification.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canadas Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

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 encourage Apply now and take the first step towards a fulfilling career at Alexion AstraZeneca Rare Disease.

#LI-Hybrid

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors including the candidates skills and experience job-related knowledge and other specific business and organizational some cases offers outside the range may also be considered to address unique circumstances.

In addition our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program 4 weeks paid vacation and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.