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Clinical Data Svs Associate

1-3 years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description – Clinical Data Services Associate (Clinical eTMF Management)

Skill Required:

Clinical Data Services – Clinical eTMF Management

Designation:

Clinical Data Services Associate

Qualification:

Bachelor of Pharmacy (B.Pharm)

Experience Required:

1 to 3 years


About Accenture

Accenture is a global professional services company with expertise in digital, cloud, and security. With unmatched experience across 40+ industries, Accenture provides:

  • Strategy & Consulting

  • Technology

  • Operations

  • Accenture Song

Driven by the world’s largest network of Advanced Technology and Intelligent Operations Centers, our 699,000 employees deliver innovation to clients in 120+ countries.


Role Overview

You will work within the Life Sciences R&D vertical, supporting global clients across the clinical development lifecycle, including:

  • Clinical trials support

  • Regulatory services

  • Pharmacovigilance

  • Patient services

You will be part of the Clinical, Pharmacovigilance & Regulatory sub-offering, ensuring high-quality clinical documentation and data integrity.


Key Responsibilities

1. Clinical Data Management Activities

  • Perform discrepancy review, query generation, and query resolution.

  • Assist in the development of CRF Completion Guidelines (CCG).

  • Support SAE reconciliation between the clinical and safety databases.

  • Identify and document protocol deviations.

2. Edit Check & Database Validation

  • Create test cases for edit check validation.

  • Write and execute test scripts for database checks.

  • Perform User Acceptance Testing (UAT) of the clinical database (CRF/eCRF).

3. eTMF (Electronic Trial Master File) Management

  • Conduct data review and accuracy checks of:

    • TMF Table of Contents

    • Initial Full Protocol Package (FPP)

    • Amended FPP checklists

    • End-of-trial checklists

  • Ensure proper essential document reconciliation.

  • Support preparation of Clinical Study Report (CSR) appendices.

4. Documentation Quality & Compliance

  • Ensure trial documentation meets:

    • Regulatory standards

    • SOPs and quality requirements

    • Sponsor and global clinical compliance expectations

5. Project Support

  • Assist in clinical data management project activities.

  • Work collaboratively with cross-functional teams to ensure data quality, completeness, and inspection readiness.