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.

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 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.

Skills Desired

Budget Management, Clinical Research, Clinical Trial Protocols, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences (Inactive), Risk Monitoring, Trend Analysis

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