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 Analyst

Accenture
Accenture
3-5 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 Analyst (eTMF Management)

Skill Required:

Clinical Data Services – Clinical eTMF Management

Designation:

Clinical Data Services Analyst

Qualification:

Bachelor of Pharmacy (B.Pharm)

Experience Level:

3 to 5 years


About Accenture

Accenture is a global professional services company with industry-leading capabilities in digital, cloud, and security. With expertise across 40+ industries, we provide services in Strategy & Consulting, Technology, Operations, and Accenture Song, supported by the world’s largest network of Advanced Technology and Intelligent Operations Centers.

Accenture’s 699,000 employees deliver innovation and human ingenuity to clients in 120+ countries. We embrace change to create value and shared success for clients, people, shareholders, partners, and communities.


What Would You Do?

You will be part of the Life Sciences R&D vertical, supporting the full lifecycle of services across:

  • Research laboratories

  • Clinical trials support

  • Regulatory services

  • Pharmacovigilance

  • Patient services

You will work within one of the sub-offerings:
Clinical, Pharmacovigilance & Regulatory, helping major biopharma clients improve outcomes by combining scientific expertise with patient insights.


Role Overview – Clinical Data Management & eTMF

You will support Clinical Data Management (CDM) and Clinical eTMF (Electronic Trial Master File) Management activities.

Key Responsibilities

1. Clinical Data Management

  • Perform data collection, integration, and validation activities.

  • Conduct discrepancy review, generate queries, and ensure timely query resolution.

  • Create CRF Completion Guidelines (CCG) and SAE Reconciliation Guidelines.

  • Identify and document protocol deviations within the clinical database.

  • Perform edit check validation, including creation of test cases and test scripts.

  • Support UAT (User Acceptance Testing) for clinical database validation.

  • Manage clinical data management projects and ensure adherence to timelines and quality standards.

2. Clinical eTMF Management

  • Perform data review and quality checks for TMF content.

  • Review and validate:

    • Trial Master File Table of Contents

    • Headquarters documents

    • Initial Full Protocol Package and amended FPP checklists

    • End-of-trial checklists

  • Conduct essential document reconciliation.

  • Support creation and review of Clinical Study Report (CSR) appendices.