Global Study Associate Manager

Are you ready to make a difference in the world of clinical research? As a Global Study Associate Manager (GSAM), you'll be at the heart of Development Operations, playing a pivotal role in the global study team. Your mission? To support the delivery of clinical studies from the development of Clinical Study Protocols (CSP) through study set-up, maintenance, close-out, and archiving. Collaborate with internal and external partners to ensure seamless execution of delegated aspects of clinical studies across various therapeutic areas and phases. Dive into a dynamic environment where your contributions will drive the success of life-changing studies!

Accountabilities:
• Support clinical study execution in collaboration with global study teams, ensuring adherence to timelines and quality standards.
• Lead the preparation of study documents and vendor-related documentation, such as the Vendor Oversight Plan.
• Facilitate interactions with cross-functional team members, including Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance.
• Collaborate with partners to execute delegated aspects of the clinical study, aligning with objectives set by the GPD, GSAD, or GSM.
• Contribute to planning and execution of internal and external meetings.
• Identify risks and issues proactively, developing mitigation and action plans.
• Support GSM in project and budget management within agreed-upon delegation.
• Participate 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.
• Ability to conduct duties in an office environment, using a computer; engaging in communications via phone, video, and electronic messaging; problem solving; collaborating; maintaining 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 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.

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 we need 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.

At AstraZeneca, you'll find yourself at the forefront of biomedical science, pushing boundaries to translate complex biology into transformative medicines. With resources and global reach, we are uniquely positioned to shape the future of rare disease treatment.

Our commitment to transparency, objectivity, and ethics drives us to meet the needs of underserved patients worldwide. Join a vibrant culture where innovation thrives, connections are built, and new ideas are explored. Empowered by tailored development programs, you'll grow alongside exceptional leaders and peers dedicated to making a difference.

Ready to embark on this exciting journey? Apply now and be part of a team that's changing lives every day!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.