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Clinical Data Svs Analyst

Accenture
Accenture
3-5 years
Not Disclosed
10 Nov. 18, 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 Title: Clinical Data Services Analyst

Job Category: Clinical Data Management / Clinical eTMF Management

Job Type: Full-Time

Qualification Required: Bachelor of Pharmacy (B. Pharm)

Experience Required: 3–5 years

Company: Accenture


About Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud, and security. With 699,000+ employees across 120+ countries, Accenture delivers Strategy & Consulting, Technology, Operations, and Accenture Song services. The company leverages technology and human ingenuity to create long-term value for clients and communities worldwide.


Role Overview

You will be part of Accenture’s Life Sciences R&D vertical, supporting global biopharma clients across research, clinical trials, regulatory operations, pharmacovigilance, and patient services.

This role falls under the sub-offering: Clinical, Pharmacovigilance & Regulatory.


Skill Requirement

Clinical Data Services – Clinical eTMF Management


Key Responsibilities

Clinical Data Management

  • Perform data management activities including:

    • Discrepancy review

    • Query generation and resolution

  • Create and maintain:

    • CRF Completion Guidelines (CCG)

    • SAE Reconciliation Guidelines

  • Identify and raise protocol deviations in the clinical database.

  • Execute edit check validation:

    • Develop test cases

    • Write test scripts

    • Conduct User Acceptance Testing (UAT) for CRF/eCRF databases

  • Manage assigned clinical data management projects.


Clinical eTMF (Electronic Trial Master File) Management

  • Review and verify accuracy of TMF content using trial master file table of contents.

  • Conduct data review and accuracy checks for:

    • Headquarters TMF documents

    • Initial Full Protocol Package (FPP) and amended FPP checklists

    • End-of-trial document checklists

  • Perform essential document reconciliation.

  • Support preparation of clinical study report (CSR) appendices.


Work Environment

You will collaborate with global clients, scientific experts, and cross-functional teams to ensure high-quality clinical data and regulatory compliance.