Clinical Operations Manager

Clinical Operations Manager

Job Description Summary

Provide operational and logistical support to clinical trials in Biomedical Research (BR) with focus on increased complexity and/or priority status. Perform defined responsibilities to support the Clinical Trial Team throughout the study lifecycle. 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 Trial Protocol, Clinical Trials, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis

Experience Level

Mid Level