Job Title
Clinical Data Services Associate
Skill Area: Clinical Data Services – Clinical eTMF Management
Experience: 1–3 Years
Qualification: Bachelor’s Degree in Life Sciences
Location: Mumbai
About the Company – Accenture
Accenture is a leading global professional services organization with capabilities in digital, cloud, and security.
Operates across 40+ industries
Offers services in:
Strategy & Consulting
Technology & Operations
Accenture Song
Powered by a global network of advanced technology and intelligent operations centers
Employs ~784,000 people serving clients in 120+ countries
The company focuses on leveraging technology and human ingenuity to drive transformation and value creation for clients, employees, shareholders, partners, and communities.
Business Unit / Domain
You will be part of the Life Sciences R&D vertical, working in areas such as:
Clinical research support
Regulatory services
Pharmacovigilance
Patient services solutions
This role contributes to helping global biopharma companies improve patient outcomes by integrating scientific expertise with patient-centric insights.
Role Overview
As a Clinical Data Services Associate, you will work on Clinical eTMF (electronic Trial Master File) Management, ensuring proper documentation, quality checks, and regulatory compliance throughout clinical trials.
You will support clinical research by managing and reviewing critical trial documentation to ensure accuracy, completeness, and audit readiness.
Key Responsibilities
1. Clinical eTMF Management
Perform TMF quality review for in-licensed TMFs at all levels
Ensure completeness and accuracy of trial documentation
Review and manage Trial Master File (TMF) content structure
2. Clinical Data Services Support
Support clinical trial data lifecycle activities including:
Data collection
Data validation
Data storage
Data review
Perform quality checks to ensure data reliability and regulatory compliance
3. Document Review & Reconciliation
Review and verify:
TMF table of contents
Protocol packages (initial and amended)
End-of-trial documentation
Essential document reconciliation
Clinical Study Report (CSR) appendices
4. Collaboration & Coordination
Work closely with TMF Managers under guidance
Coordinate with multiple stakeholders across clinical study teams
Manage communication with internal and external teams for TMF quality activities
5. Compliance & Quality Assurance
Ensure adherence to regulatory requirements and industry standards
Support inspection and audit readiness of clinical trial documentation
Maintain accuracy and consistency in TMF records
Key Skills Required
Strong client relationship management
Ability to handle disputes and resolve issues
Stakeholder management skills
Ability to work under pressure
Strong time management and ability to meet deadlines
Attention to detail and accuracy in documentation
Preferred Competencies (Implicit Expectations)
Understanding of clinical trial processes
Familiarity with TMF and clinical documentation systems
Ability to work in structured, regulated environments
Strong communication and coordination skills
Important Information
Equal Employment Opportunity
Accenture is an equal opportunity employer and does not discriminate based on:
Age
Gender identity or expression
Race
Religion
Disability
Sexual orientation
Marital status
National origin
Veteran status
Fraud Warning
Candidates are not required to pay any fee for employment at Accenture.
If anyone requests payment during recruitment, it should be reported immediately to:
india.fc.check@accenture.com
About Accenture (Mission Statement)
Accenture works with a shared purpose to deliver value through technology and human ingenuity. It fosters:
Innovation-driven work culture
Inclusive and bias-free workplace
Continuous learning and skill development
Employee well-being (physical, mental, financial)
Global recognition as a top workplace
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