Role Purpose
To support Clinical Data Management activities by ensuring accurate, complete, and high-quality clinical trial data in compliance with study protocols, SOPs, regulatory guidelines, and client requirements. The role focuses on data entry, data review, query management, documentation support, and database validation activities under the guidance of seniors and managers.
Detailed Responsibilities
· Review study protocols, CRFs, and Data Management Plans (DMP).
· Support CRF design, edit checks, and database setup activities in EDC systems.
· Perform first-pass and second-pass data entry within defined timelines.
· Conduct data review and data cleaning activities in EDC systems.
· Raise, track, and follow up on data queries with sites and study teams.
· Identify discrepancies and support timely resolution.
· Support User Acceptance Testing (UAT) activities by executing test scripts and reporting issues.
· Assist in preparation and maintenance of study documents such as DMP, Database Specifications, Edit Check Specifications (ECS), Test Scripts, and eCRF Completion Guidelines.
· Perform medical coding activities using MedDRA and WHO-DD under guidance.
· Ensure data quality, completeness, and consistency as per study protocol and SOPs.
· Maintain audit-ready documentation and trackers.
· Support database lock and archival activities.
· Coordinate with study teams for timely completion of assigned tasks.
· Escalate issues proactively to seniors or managers whenever required.
Educational Qualification
· Bachelor’s degree in Pharmacy / Life Sciences / Biotechnology / Zoology or related field
· PG Diploma / Certification in Clinical Research preferred
Experience
· 0–1 year of experience in Clinical Data Management, Clinical Research, or internship experience in related activities
· Freshers with relevant internship exposure can also be considered
Pay: ₹16,000.00 - ₹18,000.00 per month
Application Question(s):
- Have you completed internship in CDA?
Work Location: In person
