This course is mainly for the people who wants to built their career in Clinical Data Management and also for the one who wants to Switch career into Clinical Data Management . It is also applicable for the one who are already in the field of Clinical Data Management and want to upskill themselves to move up their career ladder.
I had total seven years of experience in Clinical Data Management. Currently I am working as a Senior Data Manager at Novo Nordisk. The below are the topics I have well versed in:
1. Set up phase
- Protocol
- Kickoff meeting
- Project team allocation
- CRF Designing
- Data management Plan
- Edit checks specifications
- eCRF designing
- Screen Verification ( UAT-1)
- Preparation of Data Transfer Specifications and other vendor data transfer specifications.
- Programming of edit check’s specification's.
- User Acceptance testing -2
- Database go live
2. Conduct phase
- Query management
- SAE reconciliation
- Lab. Reconciliation
- Manual checks/ SAS listings
- Technical complaint reconciliation
- Medical coding
- Change request/ Database Migration/ Protocol Ammendment
- DM metrics and reports
3. Close out phase
- Database lock checklist completion
- Freezing and Locking