Clinical Trial Specialist
Company: Unicon Pharma Inc
- Location: United States
- Seniority: Senior
- Employment type: Contract
- Posted: 5 days ago
- Offer language: English
Job description
Duties:
Job Title: Clinical Trial Transparency Specialist
The Clinical Trial Transparency Specialist is responsible for the planning, execution, and oversight of global clinical trial transparency and disclosure activities to ensure compliance with applicable regulatory, legal, and company requirements. The role serves as a subject matter expert for United States and European Union clinical trial transparency regulations, including ClinicalTrials.gov, the EU Clinical Trials Regulation (CTR), CTIS, and EMA Policy 0070 requirements. The specialist manages end-to-end transparency workflows, provides oversight of external vendors and CRO partners, and coordinates cross-functional activities to ensure timely, accurate, and compliant study registrations, results disclosures, document redactions, and public disclosure activities while protecting participant privacy and commercially confidential information.
Skills:
- 5 or more years Experience as a transparency specialist with project management experience at pharmaceutical company or equivalent
- Clinical Trial Transparency Subject Matter Expertise
- Regulatory Compliance Management
- Vendor and CRO Oversight
- Workflow and Process Management
- Cross-Functional Leadership
- Stakeholder Engagement
- Quality and Compliance Focus
- Risk Identification and Mitigation
- Continuous Improvement Mindset
- Strong Communication and Organizational Skills
- Proficiency in Microsoft Office, Adobe Acrobat, and TMF/EDMS systems
