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.
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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