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Clinical Disclosure Office Manager
hace 2 meses
The Manager, Clinical Disclosure Office plays a critical role in ensuring the quality and compliance of protocol registrations and results postings. This position is responsible for aligning with global registries, including ClinicalTrials.Gov, EudraCT, and EUCTIS, and ensuring that trial data is accurately represented in clinical registries.
Key Responsibilities- Participate in client trainings to drive quality and compliance and organizational alignment to changing disclosure requirements.
- Stay current with global policies & regulations and operational application to ensure harmonization of Novartis transparency processes and standards.
- Represent Novartis to internal stakeholders and develop effective working relationships with global and country multidisciplinary leaders.
- Maintain Standard Operating Procedures and prepare for external & internal audits.
- Apply a continuous improvement mindset to ensure best practices are shared and drive productive processes.
- Bachelor's degree in a scientific discipline preferred.
- Minimum 3 years pharmaceutical industry experience with knowledge in disclosure, including registration, maintenance, and results disclosure.
- Knowledge of drug development, experience in writing protocols, and experience in multiple clinical indications and/or therapy areas desired.
- Proven development skills in a responsible position within Clinical Research & Development, Data Management, Project Management, Medical Writing, Regulatory Affairs, or related areas.
- Ability to work within a complex cross-divisional matrix and lead multidisciplinary teams.
- Strong negotiation & conflict resolution skills, well-organized, focused on results/compliance, strong planning, tracking, problem-solving, and decision-making skills.
- Proficiency in Good Clinical Practice, Regulatory Processes, and clinical trial designs.
- Ability to adapt to changing external environments.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives, and our vision is to become the most valued and trusted medicines company in the world. We achieve this with our people, who drive us each day to reach our ambitions.
