Instagram
youtube
Facebook

Clinical Data Svs Analyst

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.