Clinical Trial Transparency Specialist (Remote)
The Fountain Group · Basking Ridge, NJ · 1 mo ago
RemoteRemoteOTHR$50–$60/hrContract
About the role
Lead global clinical trial transparency and disclosure activities for pharmaceutical clinical programs.
Responsibilities
- 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.
Qualifications
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.
Pay
$50-$60/hr.
Schedule
100% Remote — EST/CST preferred; must support EST/CST hours. Duration: 1 Year.