Job Description
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.
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Numbers & Facts
| Location | Basking Ridge, NJ (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $50–$60 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Skills
- Adobe Acrobatunmatched
- Biotech and Pharmaceuticalunmatched
- Click Through Rate (CTR)unmatched
- Clinical Practices/Protocolsunmatched
- Clinical Trialunmatched
- Continuous Improvementunmatched
- Contract Research Organization (CRO)unmatched
- Corrective Actionunmatched
- Cross-Functionalunmatched
- Improvement Metricsunmatched
- Leadershipunmatched
- Microsoft Officeunmatched
- Oncologyunmatched
- Operational Strategyunmatched
- Operations Processesunmatched
- Privacy Controlsunmatched
- Process Developmentunmatched
- Process Improvementunmatched
- Project/Program Managementunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Reporting Dashboardsunmatched
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