Soma Ghosh
SME and Business analyst, Gen AI Drug Discovery, Clinical Research Specialist, Regulatory intelligence automation, GCP certified, Experienced in Medicinal Chemistry, Clinical Data Management, Pharmacovigilance,
- Role
- Principal Business Analyst, Pharma, Regulatory, Clinical Trial Consultant at IBM
- Location
- Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Soma Ghosh
Drug Discovery,Pharma and R&D IT consultant, SME, business analysis, Data analysis in the domain of public health, genomic based discovery, medical device, safety reporting, automation of clinical trial, digitalization of clinical trial, decentralized trials, CIOMS reporting, AE, SAE reporting, Phase 0 to phase three multicentric trials in collaboration with Sanofi, IQVIA in the area of Clinical cardiology, Heart failure, Diabetes, patient recruiting, consenting, regulatory guidelines, monitoring, study start up, closing site, Design, synthesis of novel small molecule antibiotics, anti-inflammatory, kinase inhibitors with seven US/EU patents in the area of immnunooncology Key skills: Medidata Rave, KNEAT software for QMS, Preliminary training of Viva Vault, Pharma ERP software development FDA complaint, Regulatory intelligence and automationCore competency: Clinical Data management Medidata Rave, EDC, EHR, EMR, eHIS(Hospital Information system), Clinical Trial Operation, GxP regulation, KNEAT software for Computer syastem validation, Clinical Data Management, CTD submission, eCTD publishing, regulatory submission, labelling, Drug Discovery Solution, Life science projects digital transformation, AI ML based Drug Discovery Soft skills: Client communication, English communication, Team management, collaboration, presentation, Agile scrum cross functional team management
Experience
Principal Business Analyst, Pharma, Regulatory, Clinical Trial Consultant
Nov 2025 — Present · Noida, IN
SME and Business analyst for GxP regulation and Computer system Validation,KNEAT software specialist for SDLC of Pharmaceutical Products Manufacturing,automation of Research and Development, regulatory, clinical trial,AI based drug discovery solution, Viva Vault QMS software, CMC, CTD submission
Education
ICRI
PGDCRA, Clinical Research, Clinical Research, Pharmacovigilance
2017 — 2018
ICRI, Delhi
Post Graduate Diploma in Clinical Research, Clinical Research , Pharmacovigilance
Ap edusoft
SAS analytics, Analytics
2017 — 2018
Panjab University, Chandigarh
Ph.D, Organic Chemistry
1998 — 2003
Medanta Hospital
Internship, Clinical Research Coordinator
2017 — 2018
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