About the role
- 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.
- 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.
- 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.