Clinical Trial Transparency Specialist (Remote)

Serve as a subject matter expert on ClinicalTrials.gov, FDAAA 801, EU Clinical Trials Regulation (CTR), CTIS, and EMA Policy 0070 requirements. Manage end-to-end transparency workflows, including study registration, results disclosure, plain language summaries, document redaction, and public disclosure.

Job Title: Clinical Trial Transparency Specialist
Location: 100% Remote — EST/CST preferred; must support EST/CST hours
Pay Rate: $50–$60/hr.
Duration: 1 Year

Job Description

• Lead global clinical trial transparency and disclosure activities for pharmaceutical clinical programs.
• Serve as a subject matter expert on ClinicalTrials.gov, FDAAA 801, EU Clinical Trials Regulation (CTR), CTIS, and EMA Policy 0070 requirements.
• Manage end-to-end transparency workflows, including study registration, results disclosure, plain language summaries, document redaction, and public disclosure.
• Ensure accurate and compliant disclosures within applicable regulatory timelines while protecting participant privacy and commercially confidential information.
• Oversee transparency vendors, consultants, and CRO partners, including deliverable quality, compliance, timelines, and corrective actions.
• Develop and maintain disclosure plans, milestone trackers, dashboards, job aids, and operational processes.
• Coordinate cross-functional reviews and approvals and identify regulatory, quality, and timeline risks.
• Drive process improvements supporting transparency compliance and operational efficiency.

Education

• Bachelor’s degree in a relevant scientific field required.

Required Skills

• 5+ years of clinical trial transparency/disclosure experience within a pharmaceutical company or equivalent.
• Clinical trial registration and results disclosure.
• ClinicalTrials.gov / FDAAA 801
• EU CTR / CTIS
• EMA Policy 0070
• Clinical trial transparency regulatory compliance.
• Transparency workflow and project management.
• Vendor and CRO oversight.
• Document redaction and disclosure review.
• TMF/EDMS systems.
• Adobe Acrobat.
• Microsoft Office.

Preferred Skills

• Oncology clinical trial transparency and disclosure experience.
• Experience leading global transparency programs.
• Experience with commercially confidential information (CCI) and participant privacy protection.
• Experience developing transparency processes, tracking tools, metrics, and continuous improvement initiatives.

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy  #LI-SL1