Clinical Trial Transparency Specialist
Job Summary
Leading global clinical trial transparency activities, the full-time Clinical Trial Transparency Specialist will manage end-to-end workflows for study registration, results disclosure, and compliance with regulatory requirements while working remotely and supporting EST/CST hours.
Key responsibilities
- Oversee transparency workflows, ensuring accurate and compliant disclosures within regulatory timelines
- Serve as a subject matter expert on clinical trial transparency regulations and manage vendor and CRO partnerships
- Develop and maintain disclosure plans, milestone trackers, and operational processes to drive compliance and efficiency
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 CTR, CTIS, and EMA Policy 0070
- Experience with transparency workflow management and regulatory compliance
- Proficiency in TMF/EDMS systems and Microsoft Office, including Adobe Acrobat
Complete Job Description
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