CosMicIT
Website:
cosmic-it.com
Job details:
About the Role
CDST (Associate Manager)* Organized, detail oriented, ability to juggle multiple competing assignments* Hands on Study Start-Up experience that includes EDC/eCRF/Edit Check/Data Listing/Data Visual development* Technical DM that is comfortable working with technical specifications (EDC system specification, eCRF Specifications, Edit Check Specifications, Listing Specifications, Standard Specifications, metadata)* Familiarity with Clinical Data Standard Libraries and working knowledge of CDISC* Veeva EDC, Veeva CDB, Rave, Elluminate
Responsibilities
- Review Standard Change Requests and conduct standard conformance assessments
- Translate study requirements into reusable standard elements
- Develop enterprise standards that support study data cleaning and data quality (Data Listings, Edit Checks, etc)
- specification authoring/review
- test data entry
- Testing
- Support quality control review and contribute to standards documentation
- Contribute to Standard Library maintenance
- Contributes to process improvement and identifies quality risks
Qualifications
CDST (Associate Manager)
Required Skills
- Organized, detail oriented, ability to juggle multiple competing assignments
- Hands on Study Start-Up experience that includes EDC/eCRF/Edit Check/Data Listing/Data Visual development
- Technical DM that is comfortable working with technical specifications (EDC system specification, eCRF Specifications, Edit Check Specifications, Listing Specifications, Standard Specifications, metadata)
- Familiarity with Clinical Data Standard Libraries and working knowledge of CDISC
- Veeva EDC, Veeva CDB, Rave, Elluminate
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