Job Description 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, contributes to operational excellence through process improvement and knowledge sharing and/or provide inputs to clinical development process. Oversee junior colleagues’ activities related to study operations. Acts as a subject matter expert and/or cross-functional liaison.

Job Description
Major accountabilities:
- Provides operational and logistical support to clinical trials in Biomedical Research (BR)with focus on high complexity and/or priority status, in compliance with Novartis processes and Valuable Clinical Practice (GCP).
- Perform or supervise defined activities to support the Clinical Trial Team (CTT) throughout
- the study lifecycle, via study assignment and/or on-demand support.
- Maintain, share, and actively disseminate up-to-date knowledge of ICH-GCP,



external
- regulations, and internal procedures. Continuously strengthen expertise through training and practical application of Novartis Standard Operating Procedures (SOPs) and internal policies.
- Lead finalization and management of clinical, regulatory and study-related documents in
- scope of role such as study protocols, patient-facing documents, etc.
- Responsible for ownership and leading the preparation of in-scope study documents, e.g.
- Clinical Study Report (CSR) appendices, patient-facing documents, protocol training material, etc.
- Lead or oversee 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.
- Lead or oversee external communication, such as newsletter development, external
- meeting organization.
- Lead or oversee o

📌 Senior Clinical Operations Manager (Hyderabad)
🏢 Novartis
📍 Hyderabad