Clinical Data Svs Associate

Roles & Responsibilities
• Work under the guidance of the TMF Manager for assigned studies
• Perform TMF Quality Review for in-licensed Trial Master Files (TMFs) at all levels
• Review and ensure accuracy of Trial Master File table of contents
• Conduct checks on initial Full Protocol Package (FPP), amended FPP checklists, and end-of-trial checklists
• Perform essential document reconciliation and review Clinical Study Report appendices
• Identify gaps during TMF quality review and coordinate with stakeholders for resolution
• Collaborate with internal teams and action owners to close documentation gaps
• Ensure compliance with regulatory requirements and clinical trial documentation standards
• Support clinical data lifecycle management including validation and accuracy checks
• Maintain high-quality standards to support successful clinical trial outcomes

Qualification
• Bachelor’s Degree in Life Sciences
• Bachelor's degree in Pharmacy

Experience
• 1 to 3 years of experience in Clinical Data Management or eTMF Management

Skills
• Ability to establish and maintain strong client relationships
• Ability to manage multiple stakeholders effectively
• Strong problem-solving and dispute-handling skills
• Ability to meet deadlines and work under pressure
• Good organizational and documentation review skills
• Strong communication and collaboration abilities

About the Company
Accenture is a global professional services company delivering solutions in Strategy, Consulting, Technology, and Operations. Through its Life Sciences R&D vertical, Accenture supports clinical research, regulatory, and pharmacovigilance services, helping biopharma organizations improve patient outcomes and maintain regulatory compliance worldwide.