Clinical Operations Manager

Novartis Farmacéutica; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Novartis Healthcare Private Limited is seeking a Clinical Trial Operations professional to provide operational and logistical support across study lifecycles. The role emphasizes adherence to ICH-GCP, document integrity, and collaboration with global teams.

The candidate will assist in drafting and finalizing study protocols, CSR appendices, and regulatory documents, while coordinating with country organisations and external communications. A minimum of 2 years in clinical trials is expected.

Qualifications

• 2+ years’ experience in clinical trial/development.
• Adept organizational skills and quality mindset with attention to detail.
• Strong communicator with demonstrated interpersonal skills.
• Basic presentation skills and ability to mentor/train small groups.
• Ability to interact with a wide range of people, including global teams and diverse cultures.

Responsibilities

• Provide operational and logistical support to clinical trials in BR with focus on higher complexity and priority status.
• Perform activities to support the Clinical Trial Team throughout the study lifecycle.
• Maintain knowledge of ICH-GCP, regulations, and internal SOPs; apply them in practice.
• Contribute to finalization of clinical/regulatory documents and CSR appendices.
• Support interactions with Novartis country organisations and external communications.

Skills

Organizational skills

Quality mindset

Communication

Presentation skills

Mentoring/training

Team collaboration

Job description

-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 Good 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 follow-up on pending actions as necessary.
• Support and/or lead external communication such as newsletter development, external meeting organization.
• At least 2+ years’ experience in clinical trial/development.
• Adept organizational skills and quality mindset withattention to detail.
• Strong communicator with demonstrated interpersonalskills. Basic presentation skills and ability to mentor/ train small groups.
• Ability to successfully interact with a wide range ofpeople, including global teams, different cultures, diverseexperience backgrounds, etc. Ability to work in a team as well as independently if required and to manage multiple priorities

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

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 [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.