Sr. Director (Apps & Data Strategy)

Application Portfolio Scope Primary Responsibility Domain Representative Systems Regulatory Context Clinical eTMF, CTMS, EDC (Medidata/Veeva), IRT/RTSM, Safety/Pharmacovigilance (ArgOracle), eCOA/ePRO ICH E6 (R2) Google Cloud Platform, 21 CFR Part 11, EU Annex 11 Quality EQMS (Veeva Quality One / Master Control), LIMS, Batch Record (EBR/MBR), QMS, Deviation & CAPA, Change Control 21 CFR Part 11, ICH Q10, ISO 13485, EU GMP Annex 11 R&D / CMC ELN (Lab Archives / Benchling), SDMS, Formulation & St…