Clinical Operations Manager

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

Job summary

Novartis in Hyderabad, India seeks a Clinical Trial professional to provide operational and logistical support for complex trials in Biomedical Research, ensuring adherence to GCP and SOPs. You will contribute to study documentation and cross-functional coordination across country teams and external stakeholders.

The role emphasizes teamwork, attention to detail, and the ability to communicate effectively with diverse groups. Prior experience in clinical trials is required.

Qualifications

• 2+ years' experience in clinical trial/development.
• Adept organizational skills with attention to detail.
• Strong communicator with interpersonal skills; basic presentation and mentoring abilities.
• Ability to work in global teams across cultures and manage multiple priorities.

Responsibilities

• Provide operational and logistical support to clinical trials in BR per GCP.
• Perform activities to support the Clinical Trial Team throughout the study lifecycle.
• Maintain knowledge of ICH-GCP and internal SOPs; apply training.
• Assist in finalization and management of study-related documents (protocols, patient-facing documents, CSR appendices).
• Coordinate with Novartis country organizations and external communications.

Skills

Experience in clinical trials

Organizational skills

Interpersonal communication

Cross-cultural collaboration

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