- A Clinical Data Associate manages the collection, review, and cleaning of clinical trial data to ensure accuracy, integrity, and regulatory compliance. Their core responsibilities include resolving data discrepancies, performing quality control, and ensuring data is ready for statistical analysis.
- Key Responsibilities
- Data Cleaning & Review: Review data discrepancies (edit checks) and issue/resolve queries with clinical sites.
- Reconciliation: Perform Serious Adverse Event (SAE) and third-party vendor reconciliation.
- Database Operations: Assist in study start-up, Electronic Data Capture (EDC) database locking, and close-out tasks.
- Documentation: File trial documentation in the Trial Master File (TMF) and assist with database archival.
- Reporting: Track project progress and generate status or metric reports for stakeholders.
- Qualifications & Requirements
- Education: Bachelor’s degree in Biological Sciences, Life Sciences, Pharmacy, or a related healthcare field.
- Technical Skills: Familiarity with EDC systems (e.g., Medidata Rave, Oracle InForm) and clinical data management practices.
- Regulatory Knowledge: Solid understanding of ICH-GCP (Good Clinical Practice) and relevant regulatory guidelines.
- Soft Skills: Strong attention to detail, analytical problem-solving, and cross-functional communication.
- Tamil candidates only
Pay: ₹11,232.64 - ₹89,626.26 per month
Benefits:
Work Location: In person
