Job Description
Job Summary
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To perform all aspects of clinical trials registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide (disclosure operations process) as directed. To ensure compliance with the processes which support The Client’s ’s Policy for Clinical Trial Transparency and applicable regulations.
Demonstrate success in working collaboratively, independently as required, with internal and external team members to ensure The Client’s ’s Global Clinical Trial Transparency responsibilities are achieved.
Essential Functions
Performing/coordinating all activities for the registration and results posting to clinicaltrials.gov, EudraCT, and similar databases worldwide in compliance with policy and procedures, and applicable regulations.
Working closely with the internal the Client’s team and vendor to ensure they understand their roles and responsibilities related to the Client’s disclosure obligations
Disclosure Tracking Database: ensure The Client’s ’s disclosure information are maintained and in compliance with relevant procedures
Process and Training: maintain The Client’s process documents and training materials in line with regulation updates and acquired knowledge.
Required Knowledge, Skills, and Abilities
Good knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
Demonstrated experience in the pharmaceutical industry, with exposure to least one of the following areas;
Clinical trial transparency
Clinical trial disclosure
Medical Writing
Experience of supporting and managing tasks / projects, by establishing strong relationships and coordinating those resources (internal and external) to achieve deliverables in compliance with process and / or contract.
Required/Preferred Education and Licenses
BA/BS with at least 5 years (or advanced degree with at least 3 years) experience in the transparency and disclosure environment within the pharmaceutical industry. Advanced degree preferred.