Clinical Disclosure Office Manager
hace 3 semanas
About the Role
As a Clinical Disclosure Office Manager at Novartis Farmacéutica, you will play a critical role in ensuring the quality and compliance of protocol registrations and results postings. You will be responsible for aligning our global registries with international standards, including ClinicalTrials.Gov, EudraCT, and EUCTIS. Your expertise will be essential in interpreting and discussing trial data, ensuring its accurate representation 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.
- Independently represent Novartis to internal stakeholders, developing and maintaining effective working relationships with global and country multidisciplinary leaders.
- Participate in the maintenance of Standard Operating Procedures and preparations for external & internal audits.
- Apply a continuous improvement mindset, ensuring best practices are shared continually driving to the most productive processes.
Requirements:
- Bachelor's degree in a scientific discipline preferred.
- Minimum 3 years pharmaceutical industry experience with knowledge in disclosure including registration, maintenance, and results disclosure.
- Experience with ClinicalTrials.Gov, EudraCT, and the Citeline Disclose tool (also known as PharmaCM) advantageous.
- Knowledge of drug development, experience in writing protocols, 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 successfully work within complex cross-divisional matrix; previous experience leading multidisciplinary teams in matrix environment.
- 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 environment.
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. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions
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