Global Study Associate Manager

Alexion


Job Location:

Mississauga - Canada

Monthly Salary: Not Disclosed
Posted on: 15 days ago
Vacancies: 1 Vacancy

Job Summary

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire 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 unique and ambitious world.

Introduction to role

Are you ready to make a significant impact in the world of clinical research As a Global Study Associate Manager (GSAM) at AstraZeneca youll be at the heart of delivering clinical studies from inception to completion. This dynamic role involves collaborating with internal and external partners to ensure the successful execution of clinical studies across various therapeutic areas and phases. Youll lead administrative activities oversee compliance tracking systems and support vendor oversight all while contributing to the development of Clinical Study Reports and study archiving. Join us in pushing the boundaries of science and making a difference in patients lives!

Accountabilities

  • Collaborate with global study teams and key vendors to support clinical study execution ensuring adherence to timelines and quality standards.

  • Lead the preparation of study documents and vendor-related documents such as the Vendor Oversight Plan.

  • Facilitate interactions with cross-functional team members including Data Management Procurement Regulatory Patient Safety and Quality Assurance.

  • Execute delegated aspects of the clinical study in alignment with objectives set by the GPD GSAD or GSM.

  • Contribute to the planning and execution of both internal and external meetings.

  • Identify risks and issues proactively developing mitigation and action plans.

  • Support project and budget management for the GSM adhering to agreed-upon delegation.

  • Participate in or lead departmental initiatives and/or Subject Matter Expert (SME) functions.

  • Mentor team members promoting professional development and a collaborative work environment.

  • Provide support for other study and functional activities as assigned.

Essential Skills/Experience

  • Bachelors degree or equivalent in clinical practice/health care life sciences or drug development or commensurate work experience.

  • Proficiency with technological systems (Microsoft Office such as: Excel PowerPoint and SharePoint Online eTMF and Veeva Systems).

  • 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

  • Over 3 years supporting global study teams in a clinical research environment.

  • Ability to drive discussions around the scope of work and oversee vendor-related activities.

  • Excellent knowledge of Essential Documents CFR and/or ICH-GCP.

  • Demonstrated ability to collaborate as well as work independently.

  • Project management skills and basic PM methodology.

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.

#LI-Hybrid

Annual base salary for this position ranges from 81684.80 to 107211.30.

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.


Required Experience:

Manager

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire 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 ...

About Company

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Alexion is a global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders.

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