Role: Clinical Data Reviewer
Experience: 2 - 4 Years
Location: Mumbai
- Preparing eCRF specifications, Edit check specification and other study specific set up documents
- Reviewing of Protocol Deviation Document and study protocol deviations.
- Review and finalizing eCRF completion guidelines.
- Review, update and/or approve study specifications.
- Perform eCRF review and approve.
- Create/Review Test Scripts for edit checks
- Coordinate with study team for timelines and issues.
- Create UAT test scripts.
- Ensure quality for study deliverables.
- Deployment Checklist completion
- Reviewing UAT plan, UAT performance and UAT report by Clinical Data Manager.
- Review and maintenance of DMP Metrics. Weekly status meetings
- Identifying issues with validation procedures during study conduct and communicating findings to Operations manager and Client.
- Communicating site data issues (dataflow, discrepancies, etc.) with Sites, monitors, colleagues and Client as necessary.
- Supporting in execution of data listings programs and dataset reviews for patient data consistency, quality and completeness
- Utilization of appropriate data management tools to monitor quality and timeliness of data flow for assigned sites
- Identify/drive areas for process improvement for the project aligned.
- Hands-on production work along with Clinical Data Managers as and when need arises.
Job Function
BUSINESS PROCESS SERVICES
Desired Skills
Clinical Research
Desired Candidate Profile
Qualifications : BACHELOR OF PHARMACY, BACHELOR OF SCIENCE (
B.Sc Degree ), BACHELOR OF SCIENCE (
B.Sc),
M.SC.