Domain SME

Tata Consultancy Services; Dadri; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Tata Consultancy Services is seeking a Clinical Standards & Digital Data Flow Leader with a strong background in biostatistics and data standards to drive SDTM/ADaM-based solutions. This role focuses on building strategies and roadmaps for digital data flow, metadata management, and regulatory submissions.

You will co-lead global strategy from a business perspective, shape design and development, and support business development through customer interactions and strategic partnerships.

Qualifications

• Master’s degree or equivalent with domain sciences.
• Experience with SDTM/ADaM data standards and regulatory submissions.
• Ability to strategize data flow, EDC builds, and metadata management.

Responsibilities

• Contributes in building Product and solutions in Digital Data Flow by SME knowledge.
• Co-leads global strategic positioning & roadmap for Clinical Standards and Digital Data Flow.
• Co-leads design & development of these solutions from a business view.
• Supports business development with customer interactions, RFIs/RFPs, and partnerships.

Skills

Digital Data Flow

Data collection standards

Biostatistical programming SDTM

ADaM

TFLs

Regulatory Submissions

EDC

Metadata Management

AI in standardization

Education

Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent

PhD (advantage)

Job description

Role: Clinical Standards & Digital Data Flow Leader

Qualification

• Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage

Skills

• Extensive hands-on experience and Expertise with Digital Data Flow, data collection standards, biostatistical programming SDTM, ADaM, TFLs, Regulatory Submissions, EDC, and Metadata Management
• Experience in applying AI in standardization, SDTM, ADaM and TFL generation.
• Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM

Job Responsibility

• Contributes in building Product and solutions in Digital Data Flow by providing Subject Matter expertise and knowledge on Industry Trends.
• Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.)
• Co-leads the design & development for these solutions from a business view
• Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships.