Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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.