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Summary -Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. May contribute to process improvements, cross-functional collaboration, and knowledge sharing. About the Role

Major accountabilities:

- Provides operational and logistical support to clinical trials in Biomedical Research (BR) with focus on increased complexity and/or priority status, in compliance with Novartis processes and Good Clinical Practice (GCP).
- Perform defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support.
- Maintain and share up to date knowledge of ICH-GCP, external regulations, and internal procedures. Continuously enhance expertise through training and practical application of Novartis Standard Operating Procedures (SOPs) and internal policies.
- Contribute to the finalization and management of clinical, regulatory and study-related documents in scope of role such as study protocols, patient-facing documents, etc., by ensuring documents are complete, accurate, and consistent.
- Contribute and/or maintain ownership of the management and finalization of clinical, regulatory, and study-related documents such as study protocols,



patient-facing documents, Clinical Study Report (CSR) appendices, etc., by providing support to draft, review, and ensure completeness, accuracy, and consistency of these documents, as needed.
- Support and/or lead interactions and communications with relevant functions including Novartis country organizations to prepare, collect, and/or compile relevant documents, and timely follow-up on pending actions as necessary.
- Support and/or lead external communication such as newsletter development, external meeting organization.

Minimum Requirements:

- At least 2+ years' experience in clinical trial/development.
- Adept organizational skills and quality mindset withattention to detail.
- Strong communicator with demonstrated interpersonalskills. Basic presentation skills and ability to mentor/ train small groups.
- Ability to successfully interact with a wide range ofpeople, including global teams, different cultures, diverseexperience backgrounds, etc. Ability to work in a team as well as independently if required and to manage multiple priorities

Why Novartis: Helping people with disease and their families takes more than cutting-edge science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
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📌 Clinical Operations Manager (Hyderabad)
🏢 Novartis
📍 Hyderabad