Associate Clinical Data Manager (External Data)
Company: Fortrea
Job Title: Associate Clinical Data Manager (External Data)
Location: Bangalore, India
Employment Type: Full-Time
Job Requisition ID: 262857
About Fortrea
Fortrea is a global Contract Research Organization (CRO) providing clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device companies worldwide. Through advanced clinical trial management, biometrics expertise, and innovative technologies, Fortrea helps accelerate the development of therapies that improve patient outcomes globally.
Position Summary
The Associate Clinical Data Manager (External Data) is responsible for leading end-to-end Clinical Data Management activities with a specialized focus on the integration, reconciliation, quality control, and management of external clinical trial data sources.
The role provides leadership for assigned studies, manages sponsor relationships, oversees external vendor data integration activities, and ensures delivery of high-quality clinical databases from study startup through database lock. This position requires extensive collaboration with internal biometrics teams, external vendors, laboratories, safety systems, and sponsors to ensure data integrity, regulatory compliance, and successful study execution.
Key Responsibilities
Clinical Data Management Leadership
Lead Clinical Data Management activities across assigned clinical studies.
Oversee study execution from:
Protocol Review
Study Startup
Database Build
Data Validation
Data Cleaning
External Data Integration
Database Lock
Ensure all deliverables are completed within agreed timelines, quality standards, and budget requirements.
Provide leadership and guidance to Data Management team members.
External Data Management
Primary Responsibility
Manage external data received from:
Central Laboratories
Specialty Laboratories
Imaging Vendors
ECG Vendors
ePRO/eCOA Platforms
Safety Databases
Randomization Systems
Biomarker Vendors
Third-Party Clinical Technology Providers
Key Activities
Define external data transfer requirements.
Review external vendor specifications and data transfer agreements.
Monitor external data receipt and processing timelines.
Coordinate vendor issue resolution activities.
Ensure external datasets meet quality and compliance standards.
Manage external data reconciliation activities.
Data Reconciliation & Integration
Perform reconciliation between:
Clinical Database
Safety Database
Laboratory Data
Imaging Data
Vendor Data Sources
Review discrepancy reports and identify data inconsistencies.
Coordinate resolution of data issues with internal teams and external vendors.
Support batch data loading and validation processes.
Sponsor & Client Management
Act as primary Data Management contact for assigned sponsors.
Understand sponsor-specific requirements and ensure successful implementation.
Build and maintain strong client relationships.
Participate in sponsor meetings and provide project status updates.
Review client feedback and identify opportunities for service improvement.
Project Leadership
Lead data-focused project meetings.
Coordinate activities with:
Project Management
Clinical Operations
EDC Design Teams
Statistical Programming
Biostatistics
Pharmacokinetics (PK)
External Vendors
Ensure alignment across all project stakeholders.
Drive achievement of database lock milestones.
Risk Management & Issue Resolution
Identify project risks related to:
External Data Transfers
Vendor Deliverables
Data Quality
Timelines
Develop mitigation plans and corrective actions.
Escalate critical issues appropriately.
Monitor project health and proactively address potential challenges.
Data Quality & Compliance
Ensure all activities comply with:
ICH-GCP Guidelines
Study Protocols
Global SOPs
Sponsor Requirements
Regulatory Standards
Conduct quality reviews of Data Management deliverables.
Maintain complete and accurate project documentation.
Support audit readiness and inspection preparation activities.
Team Leadership & Mentorship
Provide leadership and mentorship to Clinical Data Management team members.
Support onboarding and training of new staff.
Conduct knowledge-sharing sessions and process coaching.
Assist managers with performance feedback and development planning.
Budget & Scope Management
Monitor project scope and identify changes impacting timelines or resources.
Support Project Managers with:
Scope Change Requests
Budget Discussions
Resource Planning
Ensure sponsor approvals are obtained for scope modifications.
Business Development Support
Represent Clinical Data Management during:
Bid Defense Meetings
Proposal Development
Feasibility Assessments
Sponsor Discussions
Promote Fortrea Biometrics and Data Management capabilities.
Contribute to new business opportunities.
Educational Qualifications
Required
Bachelor’s Degree in:
Life Sciences
Health Sciences
Pharmacy (B.Pharm / M.Pharm)
Biotechnology
Clinical Research
Information Technology
Biological Sciences
Related Scientific Discipline
Equivalent education and relevant experience may be considered in lieu of a formal degree.
Experience Requirements
Mandatory
6–8 years of Clinical Data Management experience.
Minimum 1 year of direct sponsor-facing experience.
Experience managing clinical trial data across multiple studies.
Experience leading study-level Data Management activities.
Preferred
3+ years of Electronic Data Capture (EDC) experience.
Experience managing external clinical trial data.
Experience within a CRO environment.
Exposure to global clinical studies.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Japan | Saitama |Tokyo :
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