Associate Clinical Data Manager
Company: Fortrea
Job Title: Associate Clinical Data Manager (ACDM)
Location: Bangalore, India
Employment Type: Full-Time
Job Requisition ID: 262855
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) dedicated to advancing clinical development through innovative technologies, scientific expertise, and operational excellence. The company partners with pharmaceutical, biotechnology, and medical device organizations worldwide to support the successful execution of clinical trials and accelerate the delivery of life-changing therapies.
Position Summary
The Associate Clinical Data Manager (ACDM) is responsible for providing end-to-end Clinical Data Management (CDM) leadership across assigned clinical studies. This role oversees all data management activities from study startup through database lock, ensuring delivery of high-quality clinical data in accordance with sponsor requirements, regulatory standards, project timelines, and budget expectations.
The position serves as the primary Data Management lead for assigned studies, working directly with sponsors, project teams, and cross-functional stakeholders to drive project execution, risk management, data quality, and operational excellence.
Key Responsibilities
Clinical Data Management Leadership
Lead Clinical Data Management activities across assigned clinical studies.
Manage data management deliverables from:
Study Startup
Database Build
Data Cleaning
Query Management
Data Reconciliation
Database Lock
Ensure all deliverables meet sponsor expectations, quality standards, and project timelines.
Provide oversight and direction to Clinical Data Management study teams.
Study Planning & Execution
Lead studies involving:
Healthy Volunteer Studies
Patient-Based Clinical Trials
Multi-Center Clinical Studies
Complex or Accelerated Timeline Projects
Develop and manage study timelines aligned with contracted milestones.
Participate in Study Initiation Meetings and project planning activities.
Coordinate study setup and operational readiness activities.
Project & Sponsor Management
Serve as the primary Data Management contact for sponsors.
Understand sponsor requirements and ensure successful implementation.
Build and maintain strong sponsor relationships.
Review client satisfaction metrics and identify improvement opportunities.
Manage scope changes and ensure appropriate sponsor approvals are obtained.
Communicate project status, risks, and deliverables to stakeholders.
Cross-Functional Team Leadership
Collaborate with:
Clinical Operations
Biostatistics
SAS Programming
PK/PD Teams
EDC Design Teams
Project Management
Sponsor Services
Lead internal data-focused project meetings and ensure alignment across functional teams.
Risk Management & Issue Resolution
Identify project risks and develop mitigation strategies.
Escalate critical issues appropriately.
Support achievement of database lock milestones.
Conduct proactive monitoring of project performance and deliverables.
Implement corrective actions when necessary.
Clinical Data Quality & Reconciliation
Ensure integrity, completeness, and accuracy of clinical trial data.
Oversee:
Data Review Activities
Query Resolution Processes
Data Validation Activities
Data Cleaning Processes
Perform and oversee reconciliation between:
Clinical Databases
Safety Databases
Laboratory Data
Third-Party Vendor Data
Support local laboratory system integrations and batch data loading processes.
Compliance & Regulatory Oversight
Ensure all activities comply with:
ICH-GCP Guidelines
Study Protocols
Sponsor Requirements
Global SOPs
Regulatory Standards
Support audits and inspection readiness activities.
Address audit findings and implement corrective actions as needed.
Team Development & Mentorship
Provide leadership and mentorship to Clinical Data Management team members.
Coach junior staff on:
Data Management Processes
Clinical Trial Operations
Quality Standards
Best Practices
Support performance evaluations and career development initiatives.
Provide constructive feedback and training support.
Business Development Support
Represent Clinical Data Management and Biometrics functions during:
New Business Opportunities
Proposal Discussions
Sponsor Meetings
Promote Fortrea's Biometrics capabilities and services.
Support project feasibility assessments and operational planning.
Continuous Improvement & Innovation
Stay updated on emerging Data Management technologies and industry trends.
Evaluate opportunities for process improvement and operational efficiency.
Support implementation of innovative data management solutions.
Promote best practices across projects and teams.
Educational Qualifications
Required
Bachelor’s Degree in:
Life Sciences
Pharmacy (B.Pharm / M.Pharm)
Biotechnology
Health Sciences
Clinical Research
Biological Sciences
Related Scientific Discipline
Equivalent education and relevant experience may be considered in lieu of formal degree requirements.
Experience Requirements
Mandatory
6–8 years of Clinical Data Management experience.
Minimum 1 year of direct sponsor management experience.
Experience leading clinical studies and managing project deliverables.
Experience working within CRO, pharmaceutical, or biotechnology environments.
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