Senior Clinical Operations Manager

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Novartis Healthcare Private Limited is seeking a Clinical Trial Project Manager to contribute to global trial activities, aiming to deliver study outcomes on time and within budget. You will oversee study operations, ensure compliance with GCP, and mentor junior colleagues within a cross-functional team.

You will act as SME and liaison across functions, preparing study documents and supporting process improvements while maintaining high standards of quality and collaboration.

Qualifications

• At least 5 to 7 years’ experience in clinical trial /development project management.
• Adept organizational skills and quality mindset with attention to detail.
• Effective verbal and written communication; proactive communication skills.
• Strong interpersonal, mentoring and training abilities.

Responsibilities

• Provide operational and logistical support to clinical trials with focus on high complexity and priority status.
• Lead finalization and management of study documents such as CSR appendices and patient-facing materials.
• Coordinate interactions with relevant functions and country organizations to prepare and follow up on actions.
• Oversee study operations activities and mentor junior colleagues.

Skills

Budget Management

Clinical Research

Clinical Trial Protocols

Clinical Trials

Coaching

Data Analysis

Data Integrity

Learning Design

Lifesciences

Risk Monitoring

Trend Analysis

Job description

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 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.

Skills Desired

Budget Management, Clinical Research, Clinical Trial Protocols, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences (Inactive), Risk Monitoring, Trend Analysis Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.