External Data Specialist
Remote from anywhere in the U.S. or Canada
Be responsible for review, maintenance and update of safety laboratory/external data received from central or local laboratories. Working to ensure departmental SOPs, guidelines and global standards are followed to maintain coding integrity and ensure consistency across all projects as appropriate
- Ensure electronic lab data contains all protocol specified lab parameters, is in correct format and data populates to the specified fields and patients correctly.
- Review data discrepancies generated by study specific edit checks for laboratory data and assist in preparation of data clarification forms sent to the site or the central lab. Also, review missing/updated central laboratory data for potential request and substitution of local laboratory data.
- Perform 100% validation review of the electronically transmitted data for 5% of total number of patients in the study for loading purposes.
- Assist CDM Manager with review of laboratory edit checks, laboratory status reports and laboratory listings as necessary.
- Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges, and maintain proper documentation.
- Enter and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database. Responsible as contact person for the External source of electronic data transmissions. Keep the Central lab and client informed of problems involving data transfers, data point issues and validation issues.
- CRF design, User Acceptance Testing (UAT) data review, and query writing experience preferred
Medical Laboratory Technology (preferred), Medical or Life Science Bachelor Degree or relevant experienceExperience:
- Minimum six (3) years relevant Clinical Data Management experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Ability to maintain confidentiality of data and information during interactions with staff at all levels
- Demonstrated computer literac
- Accurate keyboarding skills
- Thorough understanding of medical terminology
- Understanding of ICH-GCP principle
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