Clinical Operations Manager

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

Requirements

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