Clinical Standards & Digital Data Flow Leader

Tata Consultancy Services; Hyderabad; Sur place; INR 1 800 000 - 2 400 000; Plein temps

Résumé du poste

Tata Consultancy Services is seeking a Clinical Standards & Digital Data Flow Leader with 6+ years of experience in Pharma/Biotech. You will lead standards, data flow, EDC builds, and regulatory submissions, driving strategic initiatives across global stakeholders.

The role requires designing innovative digital solutions for clinical trials, supporting RFP responses, and advancing metadata management and automation across programs.

Qualifications

• 6+ years of hands-on experience in clinical data standards and data flow leadership.
• Expertise in EDC, metadata management, and regulatory submissions.
• Strong collaboration with global stakeholders and experience in CRO/pharma environment.
• Ability to design and implement digital data solutions for trials.

Responsabilités

• 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.

Connaissances

Digital Data Flow

Clinical Data Standards (CDISC)

SDTM & ADaM

EDC (Electronic Data Capture)

Metadata Repository

Regulatory Submissions

TLFs (Tables, Listings & Figures)

USDM & SDR Model

Description du poste

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