Clinical Data Services Associate

Roles & Responsibilities

• Support Clinical Data Services activities within the Life Sciences R&D vertical
• Perform Clinical eTMF (Electronic Trial Master File) management across the clinical trial lifecycle
• Conduct discrepancy review, query generation, and query resolution in clinical databases
• Support data validation, quality checks, and database accuracy reviews
• Assist in creation and review of:
– CRF Completion Guidelines (CCG)
– SAE reconciliation guidelines
• Identify, document, and escalate protocol deviations in clinical databases
• Perform edit check validation by creating test cases and test scripts
• Execute database validation (UAT) against specified CRF/eCRF requirements
• Conduct TMF quality and completeness checks including:
– Trial Master File Table of Contents
– Initial and amended Full Protocol Packages (FPP)
– End-of-trial checklists
– Essential document reconciliation
– Clinical Study Report (CSR) appendices
• Perform eCTD-compliant document format checks for regulatory submissions including:
– PDF property verification
– Bookmarking and hyperlink validation
– Compliance with Good Documentation Practices (GDP)
• Collaborate with internal and client stakeholders to ensure regulatory readiness

Qualification

• Bachelor of Pharmacy (B.Pharm)

Experience

• 1–3 years of experience in:
– Clinical Data Services
– Clinical Data Management
– Clinical eTMF management
– Regulated clinical or regulatory documentation

Skills

• Strong attention to detail and documentation accuracy
• Problem-solving and analytical skills
• Ability to work under pressure in a regulated environment
• Adaptable and flexible mindset
• Strong client relationship and stakeholder management skills

About the Organisation

Accenture is a global professional services company with leading capabilities in digital, cloud, security, and life sciences operations. With over 699,000 professionals serving clients in more than 120 countries, Accenture supports pharmaceutical and biotech organizations across research, clinical trials, regulatory services, pharmacovigilance, and patient solutions—helping bring innovative therapies to market while improving patient outcomes worldwide.