Clinical Standards & Digital Data Flow Leader

Clinical Standards & Digital Data Flow Leader

Experience: 6+ Years

Industry: Pharma / Biotech / CRO

Job Responsibilities

• Lead Clinical Standards and Digital Data Flow initiatives.
• Drive strategy for EDC builds, metadata management, and regulatory submission solutions.
• Design and develop innovative digital solutions for clinical trials.
• Support customer presentations, RFI/RFP responses, and go-to-market activities.
• Collaborate with global stakeholders to advance data standardization and automation.

Must-Have Skills

• Digital Data Flow
• Clinical Data Standards (CDISC)
• SDTM & ADaM
• EDC (Electronic Data Capture)
• Metadata Repository / Metadata Management
• Regulatory Submissions
• TFLs (Tables, Listings & Figures)
• USDM & SDR Model
• AI-driven automation in clinical data standards
• Strong stakeholder management