Clinical Data Standards Lead

Job Role - Clinical Data Standards Lead

Experience- 10+ years

Location- PAN India (Remote)

Job Description:

Skillsets

• Strong Project Management, communication, stakeholder management skills
• Experience leading cross-functional study teams and/or initiatives
• Technical DM with strong study start-up experience (ex. Edit Check/Data Listings development, spec authoring, testing)
• Prior experience working with Clinical Data Standards Libraries and working knowledge of CDISC
• Veeva EDC, Veeva CDB, Rave, Elluminate
• Leadership, mentoring, training
• Hands on-experience in process development, continuous improvement
• Process automation, AI

Tasks:

• Manage and oversee Standards development workload, timelines, deliverables (Change Requests, Conformance Assessments, Standard Library Maintenance, Process Development)
• Operationalize the development of new enterprise standards that support study data cleaning and data quality (Data Listings, Edit Checks, etc)
• Serve as CDM/CDS SME that leads the translation of study requirements into reusable standard elements
• Drive quality control review and standards documentation
• Drives process improvement and remediation strategies.

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