Clinical Trial Transparency Specialist
Job Summary
To lead global clinical trial transparency initiatives, the full-time Clinical Trial Transparency Specialist will manage end-to-end transparency workflows and ensure compliance with regulatory requirements while working remotely and supporting EST/CST hours.
Key responsibilities
- Lead global clinical trial transparency and disclosure activities for pharmaceutical programs
- Manage transparency workflows, including study registration, results disclosure, and document redaction
- Oversee transparency vendors and CRO partners, ensuring compliance and quality of deliverables
Required qualifications
- Bachelor's degree in a relevant scientific field
- 5+ years of clinical trial transparency/disclosure experience within a pharmaceutical company or equivalent
- Expertise in ClinicalTrials.gov, FDAAA 801, EU Clinical Trials Regulation, and EMA Policy 0070
- Experience with transparency workflow and project management
- Proficiency in TMF/EDMS systems and Microsoft Office
Complete Job Description
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