Instagram
youtube
Facebook

Clinical Data Svs Associate

0-2 years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Hybrid 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 Associate

Skill Focus: Clinical eTMF (Electronic Trial Master File) Management
Qualification Required: Bachelor of Pharmacy (B.Pharm)
Experience Required: 1–3 Years
Company: Accenture


About Accenture

Accenture is a global professional services company with strong capabilities in Digital, Cloud, and Security. With over 699,000 employees across 120+ countries, Accenture provides solutions in:

  • Strategy and Consulting

  • Technology and Operations Services

  • Accenture Song

The company partners with organizations to drive innovation, improve efficiency, and deliver impactful results.


Department / Business Vertical

Life Sciences R&D
This vertical supports pharmaceutical and biotech companies throughout:

  • Research & Development

  • Clinical Trials Operations

  • Regulatory Affairs

  • Pharmacovigilance

  • Patient and Medical Services


Role Overview

You will be part of the Clinical Data Management (CDM) function, responsible for ensuring the accuracy, accessibility, and regulatory compliance of clinical trial data and documents.


Key Responsibilities

  • Perform eTMF document review and quality checks as per regulatory standards.

  • Conduct technical format checks for documents required in eCTD submissions for NDA/MAA (New Drug Application / Marketing Authorization Application).

  • Verify compliance with:

    • PDF formatting requirements

    • Good Documentation Practices (GDP)

    • Bookmark and hyperlink standards

  • Support data review, discrepancy checks, and query management in clinical databases.

  • Assist in:

    • Developing CRF Completion Guidelines (CCG)

    • SAE Reconciliation Guidelines

    • Edit check validation and database User Acceptance Testing (UAT)

  • Maintain accuracy in trial master file reconciliation and ensure essential documentation completeness.


Desired Skills

Skill

Description

Adaptability & Flexibility

Ability to manage changing clinical data requirements

Attention to Detail

Ensuring accurate documentation and data consistency

Problem-Solving

Identifying data gaps and resolving discrepancies

Pressure Handling

Ability to work within timeline-driven clinical environments

Client Communication

Ability to build and maintain strong client relationships


Ideal Candidate Profile

  • Has experience in Clinical Data Management / eTMF / Regulatory Documentation

  • Understands clinical trial phases and regulatory submission requirements

  • Familiar with Good Documentation Practices (GDP) and ICH-GCP guidelines