Manager, Clinical Disclosure Office

hace 1 día

España Healthcare Businesswomen’s Association A tiempo completo

Job Description Summary
Manager, Clinical Disclosure Office, Location: Barcelona, Spain or London, UK #LI-Hybrid
The Manager, Clinical Disclosure Office ensures quality and compliant protocol registrations and results postings as well as alignment with global registries (i.e. ClinicalTrials.gov, 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.
Job Description
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 mind set 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 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.

Skills Desired

Clinical Research
Clinical Trial Protocol
Clinical Trials
Data Integrity
Learning Design
Lifesciences
Risk Monitoring
Trends Analysis

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