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.

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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 lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (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 an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.