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Domain SME- Clinical Standards and Digital Data Flow Leader

TCS · NCR

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Employer requisition: 430748

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Collected role description

TCS hiring for Clinical Standards & Digital Data Flow Leader / Clinical Biostatistical Submissions Leader Exp- 10 - 15 Years Location- PAN INDIA We are looking for an experienced & inspiring pharma leader with hands-on expertise in Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics and Data Management ( EDC, non-CRF), TFLs, SDR, USDM within-depth insights in needs, challenges and innovative trends in these domains at a global level. Qualifications and education · Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage Experience Global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA. Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation. 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 Experience in innovative ways to automate testing and validation </div

Collected minimum qualification

MASTER OF ENGINEERING, MASTER OF PHARMACY, MASTER OF SCIENCE, MASTER OF STATISTICS, MASTER OF TECHNOLOGY

Collected experience requirement

10 - 15 Years