Senior Clinical Trial Transparency Specialist
New
B
BiogenBiotechnology
Remote, USAFull-TimeSenior
Salary$116,000.00-$155,000.00
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Job Details
- Experience
- 4+ years of relevant pharmaceutical-industry experience or equivalent; 2+ years experience of global clinical trial transparency knowledge and disclosure requirements
- Required Skills
- Data management
Requirements
- Bachelor’s degree in a science related field
- 4+ years of relevant pharmaceutical-industry experience or equivalent
- 2+ years experience of global clinical trial transparency knowledge and disclosure requirements
- Experience with clinical trial registration and results disclosure activities
- Understanding of clinical study and program communication-planning dependencies
- Process mapping and continuous improvement experience
- Vendor-management experience in an outsourced operating model
- Ability to monitor deliverables, quality, timelines, metrics, and issues
- Familiarity with Clinical Trial Transparency technology, systems, and tools
- Knowledge of plain language summaries and patient-centered trial communication
- Strong cross-functional communication and stakeholder-management skills
Responsibilities
- Lead disclosure planning and delivery for assigned clinical studies
- Coordinate protocol registration, record maintenance, and results disclosure activities
- Serve as the primary Clinical Trial Transparency contact for assigned study teams
- Partner with vendors to deliver accurate, timely, high-quality registry disclosures
- Monitor vendor workload, performance metrics, cycle times, and issue logs
- Escalate disclosure risks, dependencies, and quality concerns as appropriate
- Support planning, coordination, and quality review of plain language summaries
- Improve Clinical Trial Transparency processes, work instructions, SOPs, and training
- Provide user feedback and support testing for Clinical Trial Transparency technology solutions
- Represent the function on cross-functional initiatives and continuous-improvement projects
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