Global Study Associate Manager

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 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.

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, you'll 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. You'll 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

• Bachelor’s 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

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Annual base salary for this position ranges from 81,684.80 to 107,211.30.

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 candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In 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.