- Develop and implement data management plans (DMPs), data validation strategies, and ensure compliance with relevant regulatory guidelines (e.g., FDA, EMA, ICH GCP).
- Collaborate with cross-functional teams to establish study-specific databases and data collection tools, including eCRFs (electronic case report forms), CDASH standards, and standard operating procedures (SOPs).
- Oversee the collection of clinical data from various sources, ensuring it meets high-quality standards and adheres to the study protocol. Implement and execute data cleaning procedures to resolve inconsistencies, discrepancies, and data entry errors.
- Manage the lifecycle of clinical trial databases. This includes database design, data migration, and ensuring databases are set up in compliance with regulatory standards.
- Regularly monitor and review incoming clinical data for completeness, accuracy, and consistency. Coordinate with the clinical team to resolve any data issues or queries in a timely manner.
- Generate and analyze data reports for internal stakeholders. Ensure proper documentation and tracking of data-related issues and resolutions.
Job Types: Full-time, Permanent, Fresher
Pay: ₹22,372.77 - ₹45,455.75 per month
Benefits:
- Health insurance
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person