Global Study Associate 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 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.

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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 E-Verify.