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
📌 CDST Associate Manager (India)
🏢 CosMicIT
📍 India
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