Deepak Jaybhaye

Background

About Deepak Jaybhaye

I am a passionate and detail-oriented Clinical Research professional with 13+ years of experience in Phase 1 & 2 trials and Bioavailability/Bioequivalence (BA/BE) studies, specializing in protocol development, medical writing, statistical report review, and clinical data systems. My journey began at Axis Clinicals as a Pharmacist and CRA, and I have since grown through impactful roles across VerGO Pharma, Enem Nostrum Remedies, Panexcell Clinical Lab, Teva Pharmaceuticals, and Veeda Life Sciences. Across these roles, I have contributed in: • Medical and Scientific Writing – authoring and reviewing clinical study protocols, CSRs, IBs, and narratives and submission in eCTD, SDTM. • Quality Review – ensuring accuracy, compliance, and audit-readiness of study documents (as per USFDA, EMA, DCGI standards) • Statistical Document Review – reviewing statistical protocols, SAPs, TLFs, and statistical sections of clinical reports • Designing and reviewing complex clinical studies including Inhalation, Injectable, Steady-State, Multiple Dosing, SAD/MAD, and Patient-Based PK trials • Clinical Data Management (CDM) experience – worked on eCRF development, validation, and UAT testing for EDC platforms like BizNet and CRONOS, ensuring compliance with GAMP 5 and equipment/software validation protocols for clinical instruments I hold a Master’s degree in Pharmacology (MPharm) and bring a solid scientific foundation to every project I take on. My ability to bridge the gaps between clinical operations, data management, medical writing, and regulatory expectations makes me a versatile asset in clinical research. Currently exploring global opportunities in Clinical Research, Medical Writing, Quality Review, and CDM – especially roles that value cross-functional experience and strategic thinking. Let’s connect if you’re working in drug development, early-phase clinical studies, or looking for someone who can deliver end-to-end ownership of clinical and statistical documentation.