Central Global Study Associate

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