Job Description

Job Title: Central Global Study Associate (CGSA)
Work location: Manyata tech park, Bangalore.
Introduction to role:
Are you ready to make a difference in the world of clinical studies? As a Central Global Study Associate (CGSA), you'll be part of a dynamic central team within the Development Operations Business Enablement function. Your role will be pivotal in supporting the execution of clinical study activities across various therapeutic areas and phases. This position blends administrative, operational, and coordination tasks to ensure timely and efficient delivery of clinical studies while maintaining compliance and inspection readiness. Depending on your experience level, you may hold different internal titles such as CGSA Specialist, Senior CGSA, or Principal CGSA. Are you prepared to take on additional tasks, support junior colleagues, and drive success?
Accountabilities:

• Execute tasks as requested by Global Study team members via a central ticketing platform, ensuring prompt and accurate resolution in support of study team requests. (i.e. TMF QC, Investigator Brochure site distribution etc.)
• Facilitate the setup, maintenance, closeout, and archiving of the Trial Master File (TMF), performing regular quality checks to ensure completeness and accuracy.
• Collaborate with global study teams to assist in the initiation, conduct, maintenance, and closeout of study activities.
• Populate and maintain tracking systems and communication tools; prepare and distribute study-related reports, metrics, and materials to stakeholders.
• Support the production of study documents, ensuring adherence to templates and version control, and prepare relevant documents for publishing in the regulatory document management system.
• Serve as a Subject Matter Expert for CGSA-related processes, systems, and tools, providing guidance and support as needed.
• Support training requirements for study teams and assist in site quality audits and regulatory authority inspections.

Essential Skills/Experience:

• University degree/Bachelor's degree, or equivalent experience
• Minimum of 1-3 years' experience of administrative / operational support of clinical studies with a good understanding of drug development.
• Excellent organizational, time management, and communication skills. Including proficient in English language (verbal and written).
• Proficiency in technological systems including Microsoft Office, eTMF, and Veeva Systems.
• Strong ability to prioritize tasks in a fast-paced environment and work collaboratively within a team.

Desirable Skills/Experience:

• Familiarity with ICH-GCP principles and a proactive approach to problem-solving.
• Ability to build strong relationships with peers and external partners, coupled with a focus on performance and continuous improvement.

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 an environment where innovation thrives! Our commitment to rare diseases means your work is never ordinary. We are driven by a pioneering spirit that fosters growth and creativity. With a rapidly expanding portfolio, you'll enjoy the entrepreneurial vibe of a leading biotech while making meaningful connections. Our tailored development programs empower you to align your growth with our mission, supported by exceptional leaders ready to lift you in marketing, compliance, and beyond. Here, your career is not just a path but a journey to making a difference where it truly counts.
Ready to join us on this exciting journey? Apply now and be part of something extraordinary!
Date Posted 13-Jun-2025
Closing Date 15-Jun-2025
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 . Alexion participates in E-Verify.