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- Co-ordinate with sites for site data entry and site closures.
- Study design and build, understand forms, visits, and data items collected.
- Ensure timelines set by the client in terms of discrepancies resolved and clean patient delivery are met.
- Review and resolve/action discrepancies identified by the system or through manual checks as per guidelines
- Perform discrepancy management for SAE, PV and Medical Monitor related discrepancies
- Run RAVE reports for RAVE studies to clean clinical data.
- Share study status with PDMs as when requested
- Perform data review, external data reconciliations, IVRS/external data integration.
- Perform Adhoc work or additional tasks as and when requested by clients.
- Create, Process and Action Data Clarification Forms as and when required
- Perform SAE Reconciliation based on the frequency required
- Issue clarification/follow-up until closure per the Issue Escalation Tracker process/guidelines.
- Perform query management.
- Perform discrepancy review and perform Self-Evident Corrections per DRP
- Perform SMT override, as and when required/requested.
- Perform UAT of edit checks, creation of edit check specifications and reports specifications.
- Perform form freezing/locking and understand overall database lock process.
- Good communication skills (Verbal/Written)
- Ability to manage timelines
- Analytical approach
- Bachelor’s Degree
- Minimum of 4 years of clinical data management experience (such as RAVE)
- High degree of accuracy and attention to detail
- Problem solving
Vacancy Type: Full Time
Job Location: Toronto, CA
Application Deadline: N/A