• Support Clinical Data Management (CDM) activities including discrepancy review, query management, and data validation
• Perform data quality checks to ensure accuracy, completeness, and regulatory compliance
• Manage Clinical eTMF (Electronic Trial Master File) lifecycle activities
• Conduct completeness and accuracy checks for:
– Trial Master File (TMF) Table of Contents
– Protocol packages and protocol amendments
– End-of-trial and essential document checklists
• Assist with CRF/eCRF review, edit check validation, and User Acceptance Testing (UAT)
• Identify, document, and escalate protocol deviations as per SOPs
• Support eCTD-compliant document preparation including:
– PDF property checks
– Bookmarking and hyperlink validation
• Ensure adherence to Good Documentation Practices (GDP)
• Collaborate with global cross-functional teams to support inspection and regulatory readiness
• Bachelor of Pharmacy (B.Pharm)
• 0–3 years of experience in:
– Clinical Data Services
– Clinical Data Management
– eTMF management
– Regulated clinical documentation
• Strong attention to detail and documentation accuracy
• Analytical and problem-solving skills
• Ability to work under pressure in regulated environments
• Adaptability and willingness to learn clinical systems and processes
• Effective client communication and stakeholder coordination skills
Accenture is a global professional services company with deep expertise in digital, cloud, security, and life sciences operations. With a workforce of over 790,000 professionals across 120+ countries, Accenture supports pharmaceutical and biotech companies throughout the product lifecycle—from clinical trials and clinical data management to pharmacovigilance and regulatory submissions—helping organizations deliver compliant, high-quality healthcare solutions worldwide.
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