Job Title: Senior Programmer Analyst – Custom Function (EDC / Clinical Data Programming)
Company: Fortrea
Location: Bangalore, India
Department: Data Management & Data Science
Job Type: Full-Time
Experience Required: 5–8 Years of Experience in Clinical Data Programming, EDC Systems, or Clinical Data Management
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) providing comprehensive clinical development, data management, and patient safety services to pharmaceutical, biotechnology, and medical device companies. The organization supports global clinical trials with advanced technologies, scientific expertise, and regulatory compliance to accelerate drug development and improve patient outcomes.
Role Overview
The Senior Programmer Analyst – Custom Function will be responsible for developing and implementing technical solutions related to Electronic Data Capture (EDC) systems, specifically Medidata Rave. The role involves creating and validating custom datasets, managing external clinical data integrations, and supporting reconciliation processes within clinical trial databases.
This position requires expertise in clinical programming, data management systems, and EDC platform optimization to ensure efficient clinical data collection, processing, and compliance with regulatory and Good Clinical Practice (GCP) standards.
Key Responsibilities
EDC System Development and Technical Support
Lead the development and implementation of technical solutions for issues related to Electronic Data Capture (EDC) systems, particularly Medidata Rave.
Provide technical expertise and support for clinical programming and EDC-related system challenges.
Custom Function Programming and Dataset Development
Develop, validate, and maintain custom functions and datasets used in clinical trial databases.
Manage complex programming scenarios to ensure accurate data transformation and processing.
Clinical Database Management and Enhancements
Perform post-production updates to EDC databases including enhancements to edit checks, listings, and protocol deviation tracking.
Ensure database changes align with project requirements and regulatory guidelines.
Clinical Programming Execution
Plan, execute, and oversee programming activities for assigned clinical studies.
Ensure programming deliverables meet project timelines, quality standards, and sponsor expectations.
Data Integration and Reconciliation
Manage external data imports and reconciliation processes across clinical trial datasets.
Ensure accurate and efficient integration of external clinical data sources.
Quality Control and Peer Review
Conduct peer reviews and quality control checks of study designs and clinical databases.
Ensure compliance with Fortrea Standard Operating Procedures (SOPs), Work Instructions (WIs), and study-specific guidelines.
Stakeholder Collaboration
Collaborate with data managers, programmers, and cross-functional project teams to ensure smooth execution of clinical data operations.
Participate in project meetings to review timelines, technical requirements, and deliverables.
Subject Matter Expertise
Serve as a Subject Matter Expert (SME) for EDC tools and clinical programming processes.
Act as the primary contact for technical issues related to EDC systems.
Process Improvement and Best Practices
Participate in ongoing evaluation and improvement of programming processes and clinical data workflows.
Contribute to the adoption of industry best practices and emerging technologies.
Software Validation and System Updates
Support validation activities for new software implementations and system updates.
Ensure new tools and system enhancements meet regulatory and operational requirements.
Resource Planning and Project Support
Assist with resource planning and allocate programming tasks within the project team.
Track programming progress and ensure timely completion of deliverables.
Reporting and Documentation
Generate reports, metrics, and technical documentation related to programming activities.
Demonstrate programming workflows and system capabilities to sponsors, auditors, or internal stakeholders when required.
Educational Qualifications
Bachelor’s Degree in Life Sciences, Health Sciences, Information Technology, Computer Science, or a related discipline.
Equivalent professional experience may be considered in place of formal academic qualifications.
Experience Requirements
5–8 years of hands-on experience in custom function programming or clinical data programming.
Practical experience working with EDC systems, particularly Medidata Rave.
Experience managing complex programming scenarios and clinical data workflows.
Key Skills
Clinical Data Programming
Strong experience with custom function programming and clinical dataset development.
Electronic Data Capture Systems
Expertise in Medidata Rave and other EDC platforms used in clinical trials.
Clinical Trial Data Management
Understanding of clinical trial workflows, biometrics, and clinical data management processes.
Quality Assurance and Validation
Ability to perform quality control checks and ensure compliance with clinical data standards.
Problem Solving and Analytical Skills
Strong troubleshooting capabilities for technical issues related to programming and EDC systems.
Communication and Team Collaboration
Effective verbal and written communication skills for cross-functional collaboration.
Technical Documentation
Ability to document programming processes, technical solutions, and validation activities.
Work Environment
Office-based role within a clinical research and data management environment.
Equal Opportunity Employer
Fortrea is committed to creating an inclusive workplace and provides equal employment opportunities to all qualified candidates regardless of gender, ethnicity, religion, disability, or other protected characteristics.
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