Clinical Disclosure Specialist
hace 1 día
We are seeking a skilled Clinical Disclosure Specialist to join our team in Barcelona, Spain or London, UK. This is a full-time position that offers a competitive salary range of $120,000 - $180,000 per annum.
About the RoleThe successful candidate will be responsible for ensuring quality and compliant protocol registrations and results postings as well as alignment with global registries such as ClinicalTrials.gov, EudraCT, EUCTIS, Novartis Clinical Trial Results EMA-HMA Catalogue of non-interventional studies, etc. They will also be accountable for protocol registry and results eligibility assessment and must demonstrate capability to interpret, discuss, and ensure appropriate trial data is accurately represented in clinical registries.
Key Responsibilities- Participate in client trainings within Biomedical Research and Novartis Pharmaceuticals to drive quality and compliance and organizational alignment to changing disclosure requirements.
- Responsible for staying current with global policies & regulations and operational application to ensure harmonization of Novartis transparency processes and standards.
- Independently represent Novartis to internal stakeholders. Develop and maintain effective working relationships with global and country multidisciplinary leaders, such as Study Leads, M.D.s, Legal, and Business Development & Licensing.
- 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.
Essential 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 a complex cross-divisional matrix; previous experience leading multidisciplinary teams in a 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 a changing external environment.
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