- Location
- Bengaluru, India
- Department
- Design
- Source
- Keka
Description
About the job
Job Description: Data Monitoring & eCRF Design Specialist
Role Overview
The Data Monitoring & eCRF Design Specialist will be responsible for designing, managing, and monitoring clinical trial data systems to ensure accuracy, completeness, and regulatory compliance. The role focuses on eCRF development, data validation, and ongoing data review, while supporting essential medical and regulatory documentation as required.
Key Responsibilities
Data Monitoring & Management
- Design, develop, and maintain electronic Case Report Forms (eCRFs) using Zoho Database in alignment with study protocols, CRFs, and regulatory requirements.
- Collaborate with clinical operations, investigators, and study teams to understand data collection needs and translate them into user-friendly and compliant eCRF designs.
- Perform ongoing data monitoring to ensure data accuracy, consistency, completeness, and timeliness across clinical studies.
- Conduct quality checks, query management, and discrepancy resolution in coordination with site teams and internal stakeholders.
- Troubleshoot and resolve issues related to eCRF functionality, data flow, and system usability.
- Provide controlled access to eCRFs for study teams and support UAT (User Acceptance Testing) and quality reviews.
- Ensure adherence to GCP, protocol requirements, and applicable regulatory guidelines in all data-related activities.
- Support data lock activities and ensure readiness of clean datasets for analysis and reporting.
Regulatory & Clinical Documentation Support
- Support preparation, review, and maintenance of clinical and regulatory documents related to data collection and reporting.
- Review clinical documents prepared by internal teams for data consistency, clarity, and compliance.
Collaboration & Project Management
- Coordinate with internal teams, sponsors, investigators, and external consultants to align on data requirements, timelines, and deliverables.
- Manage multiple studies and data-related tasks simultaneously while maintaining high quality and meeting timelines.
- Perform any additional responsibilities related to data management and study support as assigned by management.
Skills
GCPComplianceProject Management