Senior Specialist Clinical Trial Transparency
On-site · Bengaluru, Karnataka, India
Job Summary
Lead and coordinate clinical trial transparency activities across assigned studies and programs, from trial registration through results disclosure in registries (ClinicalTrials.gov, CTIS, local registers). Manage registry maintenance, data review for completeness and accuracy, and lead document redaction/anonymization for public disclosure per regulatory requirements. Partner with cross-functional teams to monitor deadlines, maintain compliance, and support audit/inspection readiness. Requires 5+ years in clinical research with knowledge of global registries and disclosure systems; experience with regulatory requirements and data protection. Proficiency with Office 365, Adobe Acrobat, and AI in regulated environments. Degree in life sciences or healthcare discipline. Based in Bangalore, India; travel not specified. Best suited for senior professionals taking end-to-end ownership in trial transparency and disclosure excellence.
Required Qualifications
- At least 5 years of experience in clinical research within CRO, study site, pharmaceutical, or biotechnology
- Strong hands-on experience in clinical trial disclosure and transparency
- Knowledge of global clinical trial registries (ClinicalTrials.gov, CTIS)
- Experience with disclosure systems such as PharmaCM/Disclose or PRIME
- Proficiency with Microsoft Office 365 and Adobe Acrobat in regulated environments
- Ability to review registry content for accuracy and perform anonymization/redaction
- Ability to interpret global, regional, and local transparency regulations
- Strong communication and cross-functional collaboration skills
- Degree in life sciences or a healthcare-related discipline
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