About the role
TCS is Hiring for
Role: Domain SME
Experience: 8 Years to 10 Years
Location : Mumbai, Pune, Bangalore, Hyderabad
Role & Responsibilities
oMaster’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage
o6+ years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs)
oExtensive hands-on experience and Expertise with Digital Data Flow, data collection standards, biostatistical programming SDTM, ADaM, TFLs, Regulatory Submissions, EDC, and Metadata Management
oExperien ce in applying AI in standardization, SDTM, ADaM and TFL generation.
oExperience in strategy setting for generating EDC build from study protocol, SDR Model, USDM
oExperience in innovative ways to automate testing and validation
oStrong stakeholder engagement and communication skills
o Background in Pharma, Biotech, or CRO organizations
Qualifications: BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), MASTER OF PHARMACY, MASTER OF SCIENCE