Clinical Data Management

Position: Clinical Data Coordinator

Role Summary

The purpose of this position is to perform Data Management activities for successful execution of all DM projects.

Role & responsibilities

• Review project documents such as protocols, CRFs (or eCRFs and eDiary), CRF (eCRF) completion guidelines, Data Entry Guidelines etc, perform UAT of Database and Edit Checks, along with generation of Test Scripts.
• Develop study documents such as Data Management Plan, Data Validation Specifications, Global Ruling, Coding Guidelines, SAE reconciliation plan, QC plan etc. Performing UAT, Edit check testing etc.
• Data review in accordance with Data Management Plan and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data, including monitoring of external data, electronic data inventory reconciliation, aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies.
• Ensure data quality is acceptable and there are no major or critical findings post DB lock
• Follow up with the project team on issues and concerns.
• Perform Oversight of outsourced studies
• Perform other duties as directed by reporting Manager or higher.
• Contribution towards technology/process improvement, SOP development.
• Develop skills and manage performance of direct reports/peers.

Preferred candidate profile

• Candidate should be able to take initiative and complete tasks
• Should have hands on experience in Oracle Clinical/ Rave /InForm