Clinical Trial Disclosure And Transparency Associatemanager Job In Barnet

Job Summary

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.