About this role
Senior Clinical Operations Manager
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.
About the Role
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 Good 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 other study operations support activities (e.g. on-demand operations support, Trial Master File metrics).
Minimum Requirements: -- At least 5 to 7 years’ experience in clinical trial /development -- Project management experience evidenced by the ability to organize effectively and deliver results -- Adept organizational skills and quality mindset with attention to detail. -- Effective communication (verbal and written); proactive communication skills. -- Well-developed interpersonal skills with the ability to build rapport, manage, and coach others. -- Solid presentation skills and ability to mentor / train small groups.
Why Novartis: Helping people with disease and their families takes more than innovative 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. Read our handbook (PDF 30 MB)
Division Biomedical Research
Business Unit Research
Location
India
Site Hyderabad (Office)
Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area Research & Development
Job Type Full time
Employment Type Regular
Shift Work No
Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Job ID
REQ-10087854
Senior Clinical Operations Manager
Apply to Job
Job ID
REQ-10087854
Senior Clinical Operations Manager
Apply to Job