1.Ensures electronic vendor data contains all protocol specified parameters, is in correct format, and data populates to the specified fields and patients correctly.
2. Develop the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.
3. Review data discrepancies generated by study specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
4. Perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes.
5. Assist with review of laboratory edit checks, laboratory status reports and laboratory listings.
6. Work with clinical staff to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning normal ranges and maintain proper documentation.
7. Edit and perform QC for local laboratory normal ranges. Verify that normal ranges are properly attached to patient results in the local lab data collection module.
8. Communicate to vendors and client problems involving data transfers, data point issues, and validation issues.
9. Assist with training new team members.
10. Perform other duties as required by the Department
- Associates or bachelor’s degree in Medical/Life Science/Computer Science or equivalent combination of education and experience to successfully perform the key responsibilities of the job.
- Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
- Broad knowledge of drug development process.
- Knowledge of effective external data management practices.
- Understanding of global clinical development budgets and relationship to productivity targets.
- 4+ yrs of relevant experience in CDM or EDS
- Demonstrated leadership and interpersonal skills.
- Strong organizational, planning, and critical-thinking skills.
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