Senior Clinical Trial Transparency Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the planning and execution of disclosure for designated clinical studies.

• Manage protocol registration, record upkeep, and results disclosure activities.

• Act as the main Clinical Trial Transparency liaison for assigned study teams.

• Collaborate with vendors to ensure accurate, timely, and high-quality registry disclosures.

• Track vendor workload, performance metrics, cycle times, and issue logs.

• Raise disclosure risks, dependencies, and quality issues when necessary.

• Assist in the planning, coordination, and quality assessment of plain language summaries.

• Enhance Clinical Trial Transparency processes, work instructions, SOPs, and training materials.

• Offer user feedback and assist in testing for Clinical Trial Transparency technology solutions.

• Represent the function in cross-functional initiatives and continuous improvement projects.

• Collaborate closely with Clinical Development, Regulatory Affairs, Medical Writing, Data Management, and external service providers.

⛳️ Requirements

• Bachelor's degree in a scientific discipline.

• 4+ years of pertinent experience in the pharmaceutical industry or equivalent.

• 2+ years of experience with global clinical trial transparency knowledge and disclosure regulations.

• Familiarity with clinical trial registration and results disclosure processes.

• Understanding of dependencies in clinical study and program communication planning.

• Experience in process mapping and continuous improvement initiatives.

• Vendor management experience within an outsourced operational model.

• Capability to monitor deliverables, quality, timelines, metrics, and issues.

• Knowledge of Clinical Trial Transparency technology, systems, and tools.

• Awareness of plain language summaries and patient-centered trial communication.

• Excellent cross-functional communication and stakeholder management skills.

• Preferred: Experience in supporting or leading updates to SOPs, work instructions, or training.

• Preferred: Familiarity with data sharing, patient engagement, health equity, or digital engagement.

🏝️ Benefits

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

• Medical, Dental, Vision, & Life insurance coverage.

• Fitness & Wellness programs, including reimbursement for fitness-related expenses.

• Short- and Long-Term Disability insurance.

• A minimum of 15 days of paid vacation.

• Year-end shutdown time off (December 26 to December 31).

• Up to 12 company-paid holidays.

• 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Involvement in Employee Resource Groups.