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Clinical Data Svs Associate

0-2 years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Clinical Data Services Associate – Structured Job Description

Job ID: AIOC-S01612904
Location: Hyderabad
Experience: 1–3 years
Qualification: Bachelor of Pharmacy
Type: Full-Time


1. Role Overview

You will work within Accenture’s Life Sciences R&D vertical, specifically supporting Clinical Data Services, Clinical Trials, Pharmacovigilance, and Regulatory functions.
Your primary responsibility is Clinical eTMF Management and document format checks for eCTD-compliant submissions.


2. Key Responsibilities

A. Clinical Data & TMF Management

  • Perform data management activities, including:

    • Discrepancy review

    • Query generation and resolution

    • Protocol deviation identification

  • Support creation of:

    • CRF Completion Guidelines (CCG)

    • SAE Reconciliation Guidelines

  • Execute:

    • Edit check validation

    • Test case creation

    • Test script writing

    • User Acceptance Testing (UAT) of clinical databases

  • Manage clinical data management tasks across trial lifecycle.

B. eTMF (Electronic Trial Master File) Activities

  • Perform accuracy checks for:

    • TMF table of contents

    • Initial full protocol packages

    • Amended protocol packages

    • End-of-trial checklists

    • Essential document reconciliation

    • CSR (Clinical Study Report) appendices review

C. eCTD Document Format Checks

As a Document Administrator, you will:

  • Conduct format checks for documents requiring eCTD compliance for NDA/MAA submissions.

  • Verify:

    • PDF technical properties

    • Bookmark/hyperlink accuracy

    • Compliance with Good Documentation Practices (GDP)

    • Document formatting against eCTD standards


3. Skills Required

  • Adaptability & flexibility

  • Ability to perform under pressure

  • Strong problem-solving skills

  • High attention to detail

  • Ability to manage strong client relationships


4. About Accenture

A global professional services company known for capabilities across:

  • Digital

  • Cloud

  • Security

  • Strategy & Consulting

  • Technology

  • Operations

  • Accenture Song

Present in over 120 countries with 775,000+ employees, focused on innovation and human ingenuity.


5. Equal Opportunity Statement

Accenture ensures equal employment opportunities without discrimination based on:

  • Age, race, religion, gender, disability, veteran status, sexual orientation, marital status, nationality, etc.

Accenture also warns against fraudulent recruitment messages requesting payment—no payment is required at any step.