Job Title
Associate Clinical Data Manager
Company
Fortrea
Location
Bangalore, India
Employment Type
Full-time
Job Overview
This is a clinical data management leadership role where you will oversee end-to-end data management activities for clinical trials—from study start-up to database lock. You will work closely with sponsors and cross-functional teams to ensure high-quality clinical data delivery within timelines and budget.
Key Responsibilities
1. Study Leadership & Data Management Ownership
Lead clinical data management (DM) activities for assigned studies
Own deliverables from study start-up to database lock
Ensure compliance with:
Study protocols
GCP (Good Clinical Practice)
Global SOPs
Manage timelines, budgets, and study milestones
2. Project Planning & Coordination
Work with Project Managers to build study timelines
Coordinate with cross-functional teams:
EDC Design
SAS Programming
Statistics
PK (Pharmacokinetics)
Identify risks and provide mitigation strategies
Ensure timely database lock
3. Sponsor & Client Management
Work directly with sponsors to understand requirements
Manage scope changes and ensure approvals
Maintain client relationships and satisfaction
Represent Data Management in client meetings and audits
4. Data Quality & Validation
Ensure high-quality clinical data output
Perform reconciliation with:
Safety data
Laboratory data
Third-party data
Ensure accuracy and consistency of clinical databases
5. Leadership & Mentoring
Provide guidance to junior DM team members
Review team outputs for quality assurance
Support training and development of staff
Provide performance feedback
6. Compliance & Documentation
Maintain accurate project documentation
Support audits (internal and external)
Resolve audit findings within timelines
Ensure adherence to SOPs and regulatory standards
7. Process Improvement & Innovation
Evaluate and adopt new DM technologies
Improve data management processes
Contribute to operational efficiency initiatives
Stay updated with industry trends
Required Qualifications
University/College degree (Life Sciences preferred)
Equivalent experience accepted in lieu of degree
Required Experience
6–8 years in Clinical Data Management
At least 1 year of direct sponsor/client management experience
Experience in:
Clinical trials
Data management systems (EDC)
Clinical operations or biometrics
Required Skills
Technical Skills
Clinical Data Management systems (EDC, CTMS, etc.)
Clinical trial processes
Data reconciliation and validation
Knowledge of medical terminology
Understanding of biometrics workflows
Core Competencies
Strong leadership and coordination skills
Excellent time and project management
Strong attention to detail
Ability to manage budgets and scope
Risk identification and mitigation
Soft Skills
Strong communication skills (written & verbal)
Client relationship management
Team collaboration
Problem-solving ability
Ability to work under pressure and deadlines
Preferred Skills
Background in life sciences or health sciences
Knowledge of Fortrea systems and SOPs
Experience with Electronic Data Capture (EDC) systems (3+ years preferred)
Work Environment
Hybrid / office / home-based flexible model
May require overtime and weekend work
Global collaboration with sponsors and study teams
Role Summary (Simple Explanation)
This is a mid-to-senior clinical data management leadership role where you will:
Lead clinical trial data operations
Manage sponsors and client requirements
Oversee database setup, quality, and lock
Coordinate multiple clinical teams
Handle budgets, timelines, and scope changes
Ensure regulatory compliance and audit readiness
Key Insight
This is a senior role (6–8 years experience)
One of the highest-level clinical data management roles you shared so far
Strong path toward:
Clinical Data Manager → Senior Manager → Director roles
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