Clinical Operations Manager (India)

Clinical Operations Manager (India)

21 Sep
|
Novartis
|
India

21 Sep

Novartis

India

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. 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 Positive 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 fol

📌 Clinical Operations Manager (India)
🏢 Novartis
📍 India

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