Senior Clinical Data Analyst (Home-based) - UK, Poland, or South Africa - FSP
PLN 195K-223K Senior-level Full Time
Tasks
- Conduct training for employees and contractors
- Coordinate EDC design and testing
- Design eCRFs and completion guidelines
- Develop data edit check specifications
- Develop data listings
- Develop data management plans
- Lead clinical studies
- Lead database upgrades and migrations
- Maintain study workbooks and data management files
- Manage data management activities with CROs and vendors
- Mentor data management staff
- Perform database lock and freeze
- Perform header data reconciliation
- Perform serious adverse event reconciliation
- Perform user acceptance testing
- Provide EDC training
- Provide eCRF completion guidelines training
- Provide input to data management SOPs and work instructions
- Represent Data Management on CTWG
- Resolve EDC system issues
- Review clinical monitoring plans
- Review eCRF data requirements
- Review protocols for data capture
- Review statistical analysis plans
- Review vendor specifications
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR 11 | Acceptance Testing | Adverse Event | Analysis Plan | CDISC | CFR 11) | Case Report Form | Clinical Monitoring Plan | Clinical monitoring | Clinical trials | Data Capture | Data Edit Checks | Data Listings | Data Management | Data Management Plan | Data Reconciliation | Database Freeze | Database lock | ECRF | EDC | Edit checks | Electronic Case Report | Electronic Case Report Form | Electronic Data | Electronic data capture | FDA | GCDMP | GCP | ICH | MedDRA | Monitoring Plan | Protocol review | Rave | S&OP | Serious Adverse Event | Statistical Analysis | Statistical Analysis Plan | User Acceptance | User Acceptance Testing | WHO Drug | WHO Drug Dictionaries
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