Senior Manager, Clinical Disclosure Office
Job ID REQ-10045137
Mar 25, 2025
United Kingdom
Summary
Independently ensure all tasks and deliverables within the Registration and Results Disclosure area of the Clinical Disclosure Office (CDO) are managed with high quality and in compliance with internal and external regulations. Ensure efficient and timely registration, maintenance, and results disclosure in public registries for both Novartis Interventional and Novartis drug Non-Interventional Studies.
About the Role
Major Accountabilities:
* Perform eligibility assessment, registration, maintenance and results disclosure for assigned clinical studies on public registries such as clinicaltrials.gov according to internal and external requirements.
* Ensure study data/information (protocol, CSR) is accurately represented and maintained on public registries.
* Collaborate with clinical teams (such as Study Leads, M.D.s, Medical Writers, Statistical Programmers, IP attorneys) to align on all aspects related to disclosure.
* Organize and conduct routine client trainings on CDO processes.
* Contribute to the redesign and maintenance of Standard Operating Procedures and training materials.
Requirements
* University or college degree (BSc) in Life Sciences, Natural Sciences, Statistics, Medical Informatics or equivalent long-term professional experience.
* Minimum 3 years of experience in clinical trial disclosure with significant experience related to the conduct and analysis of clinical trials.
* Advanced understanding of global legislations, regulations and guidelines.
* Knowledge of Good Clinical Practice (GCP) regulations.
* Flexible, willing to adapt, willing to speak-up and challenge.
* Experience in developing effective working relationships with internal and external stakeholders.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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