Clinical Operations Manager

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

Job summary

Novartis India is seeking a Clinical Trial Assistant to contribute to global clinical trial activities, ensuring study outcomes meet schedule, budget, quality/compliance and performance standards. You will be a core member of the Clinical Trial Team and may lead specific aspects.

This role provides operational and logistical support across study lifecycle, maintains ICH-GCP knowledge, and supports document finalization and cross-functional communication with Novartis country organizations.

Qualifications

• 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

Responsibilities

• 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, 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.

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.

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 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.

Minimum Requirements

• 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

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

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