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Manager, Clinical Disclosure Office
hace 3 meses
Summary:
Manager, Clinical Disclosure Office, Location:
Barcelona, Spain, #LI-Hybrid The Manager, Clinical Disclosure Office ensures quality and compliant protocol registrations and results postings as well as alignment with global registries , EudraCT, EUCTIS, Novartis Clinical Trial Results EMA-HMA Catalogue of non-interventional studies etc.) with oversight.
They are also 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.
About the Role:
Key Responsibilities:
- Participate in client trainings within Biomedical Research and Novartis Pharmaceuticals to drive quality and compliance and organizational alignment to changing disclosure requirements.
- 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.
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 , EudraCT and the Citeline Disclose tool (also known as PharmaCM) advantageous)
- 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?
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
DivisionDevelopment
Business Unit
Pharmaceuticals
Location
Spain
Site
Barcelona Gran Vía
Company / Legal Entity
ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
