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
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