Clinical Operations Manager

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Novartis Healthcare Private Limited in Hyderabad, India, is seeking a Clinical Trial Support professional to contribute to global clinical trial activities. The role emphasizes operational and logistical support across the study lifecycle, with oversight for documentation and adherence to GCP.

The position requires at least 2 years in clinical trial/development, strong organizational skills, and the ability to collaborate with global teams.

Qualifications

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

Responsibilities

• Provides operational and logistical support to clinical trials in Biomedical Research with focus on increased complexity and/or priority status, in compliance with Novartis processes and GCP.
• Perform defined activities to support the Clinical Trial Team throughout the study lifecycle.
• Maintain and share up-to-date knowledge of ICH-GCP, external regulations, and internal procedures.
• Contribute to the finalization and management of clinical, regulatory, and study-related documents (e.g., study protocols, CSR appendices).
• Support and/or lead interactions with relevant functions to prepare, collect, and follow up on pending actions.
• Assist external communications such as newsletter development and external meeting organization.

Skills

Clinical Research

Clinical Trials

Data Integrity

Learning Design

Risk Monitoring

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. May contribute to process improvements, cross-functional collaboration, and knowledge sharing.

Job Description 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 with attention to detail.
• Strong communicator with demonstrated interpersonal skills.
• Basic presentation skills and ability to mentor/ train small groups.
• Ability to successfully interact with a wide range of people, including global teams, different cultures, diverse experience backgrounds, etc.
• Ability to work in a team as well as independently if required and to manage multiple priorities.

Skills Desired

• Clinical Research
• Clinical Trials
• Data Integrity
• Learning Design
• Risk Monitoring

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.