Sr. Clinical Trials Transparency & Disclosure Specialist

Responsibilities

• Manage the planning, execution, and oversight of global clinical trial registration and results disclosure activities in accordance with applicable regulations and company policies.
• Ensure timely and accurate registration, maintenance, and updating of clinical trial records in public registries, including ClinicalTrials.gov, CTIS, and other applicable regional registries.
• Cook up the preparation, review, and submission of clinical trial results disclosures in accordance with applicable regulations and company timelines.
• Monitor evolving global disclosure regulations and industry guidance, assessing impact on company processes and compliance requirements.
• Maintain complete and inspection-ready disclosure documentation, records, and compliance metrics.
• Partner with cross-functional teams to gather required information and ensure accurate and consistent public reporting of clinical trial information.
• Provide strategic guidance and operational support for transparency and disclosure activities throughout the clinical development lifecycle.
• Serve as a subject matter expert and resource for transparency and disclosure requirements across the organization.

Qualifications

• Bachelor's degree in Life Sciences, Public Health, Regulatory Affairs, Clinical Research, or a related discipline; or an equivalent combination of education, training, and relevant professional experience.
• 3–5 years of experience in clinical research, clinical operations, regulatory affairs, clinical disclosure, or a related pharmaceutical/biotechnology function.
• Experience working with ClinicalTrials.gov, CTIS, EudraCT, or similar clinical trial registries preferred.
• Familiarity with global clinical trial disclosure requirements, including FDAAA, EU Clinical Trial Regulation (CTR), and other applicable transparency requirements.
• Experience working in a GCP-regulated environment.
• Understanding of clinical trial processes and clinical development.
• Knowledge of clinical trial transparency and disclosure requirements.
• Excellent attention to detail and commitment to accuracy.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Proficiency with Microsoft Office applications and clinical systems.
• Accountability and ownership of assigned deliverables.
• Proactive and solutions-oriented approach.
• Commitment to compliance, quality, and continuous improvement.
• Ability to build collaborative relationships across departments and with external partners.
• High level of professionalism, integrity, and attention to detail.