Domain SME

Domain SME (Clinical Standards & Digital Data Flow Leader)

Experience: 8+ Years

Location: PAN India

CTC: Up to 40 LPA

Industry: Life Sciences / Pharma / CRO

Key Responsibilities

• Provide subject matter expertise in Clinical Standards and Digital Data Flow to support product and solution development.
• Define and contribute to strategic positioning and roadmap for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics and Data Management solutions.
• Support the development of differentiated solutions and product offerings for the Pharma and Life Sciences industry.
• Provide business and domain expertise for solutions involving SDTM, ADaM, TFLs, EDC, SDR, USDM and regulatory submission packages.
• Identify opportunities for automation, AI and innovative technologies across clinical data standardization and submission processes.
• Support strategy for generating EDC builds from study protocols and implementing SDR/USDM models.
• Drive innovative approaches to testing, validation and quality control.
• Support customer presentations, RFI/RFP responses and go-to-market strategies.
• Contribute to thought leadership through industry articles, webinars, conferences and advisory forums.
• Build and maintain strong relationships with senior stakeholders, Pharma organizations, CROs and industry partners.
• Represent the organization in relevant industry forums and standards organizations such as CDISC, TransCelerate and IMI.

Key Areas of Expertise

• Clinical Data Standards and CDISC frameworks
• SDTM, ADaM and regulatory submission packages
• Digital Data Flow and Clinical Data Flow strategy
• Metadata Repository
• Biometrics and Clinical Data Management
• EDC, non-CRF data and eDTA
• TFL development and regulatory reporting
• SDR Model and USDM

Interested candidates can share their updated CV at [Confidential Information] & [HIDDEN TEXT]