Band Level 3 Job Description Summary
The Clinical Operations Manager provides clinical leadership and strategic input for all clinical deliverables across assigned projects and programs within BR/TM.
Key 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).
* Performs defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support.
* Maintains and shares up-to-date knowledge of ICH-GCP, external regulations, and internal procedures.
* Enhances expertise through training and practical application of Novartis Standard Operating Procedures (SOPs) and internal policies.
* Contributes to the finalization and management of clinical, regulatory, and study-related documents in scope of role such as study protocols, patient‑facing documents, and Consensus and Clinical Study Report (CSR) appendices.
* Supports and/or leads interactions and communications with relevant functions, including Novartis country organizations, to prepare, collect, and compile relevant documents, and timely follow‑up on pending actions.
* Supports and/or leads external communication such as newsletter development and external meeting organization.
* Contributes to or oversees other study operations support activities (e.g., on‑demand operations support, Trial Master File metrics).
* Ensures accuracy and completeness of clinical trial management databases and trial related systems (e.g., Clinical Trial Management System, Novartis Connect), providing information, timely updates, and inputs, and following up on questions as necessary.
* Checks for or proactively identifies discrepancies and takes actions to correct as necessary.
* Identifies, contributes, and/or leads areas for process or technology improvements regarding activities undertaken within the role.
* Supports and/or leads business logistics through the collection or collation of clinical trial supportive systems access and materials in scope of role (e.g., clinical trial application, end of trial, organizing external meetings, following up required signatures).
* Supports and/or owns onboarding and training of others (associates, peers, new starters) by providing on‑the‑job guidance, training, demos, updates, etc. for assigned mentees or for the community.
* May function as Subject Matter Expert (SME) in areas of expertise and represent Study Operations in cross‑functional and divisional initiatives and workstreams.
Essential Requirements
* Relevant experience in the pharmaceutical industry, biotechnology, or CRO drug‑development environment with a solid understanding of the drug development process, and early clinical development preferred.
* 1+ years’ experience in early‑phase clinical trials operations.
* Solid knowledge of clinical trials site selection, global/country‑specific requirements, timelines, and challenges in clinical trial execution process.
Desirable Requirements
* Successful completion of Academy fellowship program.
Accessibility and Accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e‑mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Data Management, Detail‑Oriented, Health Sciences, Life Sciences, Negotiation Skills, Project Planning, Waterfall Model.
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