Soma Ghosh

Dynamic healthcare IT consultant with extensive experience at Birlasoft, excelling in clinical trial management and drug discovery. Proven track record in patient recruitment and data management using Medidata Rave. Strong analytical skills complemented by effective project management, leading to award-winning public health initiatives and innovative research contributions.

• GCP
• GxP
• Business Analyst
• Agile
• Regulatory Submission
• Clinical Trial Medidata Rave
• Electronic Data Capture
• Medical Device Safety Assessment
• JIRA
• Project Management
• Microsoft Visio (ongoing)
• DSUR
• PSUR
• Regulatory Labelling
• Submission
• Patient Narrative Automation using Gene AI

• Intelligent Automation JnJ, Generative AI creation of patient narratives, Clinical Trial protocol, case safety reporting, SMPC use cases, regulatory labelling as per EMA guidelines.
• ADMABIO, Regulatory guidelines on computer system validation, 21CFR11 SOP analysis, business requirement analysis.
• QuVa Pharma, Pharma ERP software comparison and analysis, create ASIS, To be document, gap analysis, Business process recommendation, Regulatory compliance analysis, Validation software, FDA validation recommendation.
• Drug Discovery and Novel Target identification, Drug disease Association, Targeted discovery, Precision medicines use case preparation, intelligent documentation for Discovery Research.
• AICOMODO, Business requirement generation for dashboard creation for preclinical data requirements.

• Advance trends in telehealth, 04/01/22, S. Ghosh, R. Saxena, https://www.researchgate.net/publication/359938586_Advance_trends_in_Tele_Health
• Exploring the use and acceptance of TELEMEDICINE for patient remote monitoring during COVID-19 Pandemic LITERATURE REVIEW, 09/01/21, Jimmy Banda, S. Ghosh, 10.13140/RG.2.2.36687.00169

Physiochemical characterization and in vitro dissolution behavior of celecoxib-beta-cyclodextrin inclusion complex., V.R. Sinha, R.Anitha, Ghosh S, Amita, R.Kumaria, R Vinge, M. Kumar, Acta Pharm., 2007, Complexation of Celecoxib with cyclodextrin, characterization of complex in solid and solution phase., V.R.Sinha, R. Anitha, Ghosh S., J. Pharm. Sci, 2005, Origin of 1,3 interaction in the addition of alkyl lithium to imines bearing N-stereogenic., Nancy, Ghosh. S, Nishan, Gurmeet Kaur, P.V. Bharatam, Trehan. S, Chem.Comm, 2003, US 9,364,466, 2016, Heterocyclic compound as protein kinase inhibitor, PCT 2015/0157,613, 2015, Heterocyclic compound as Tyk-2 inhibitor, US 8,980,911, 2015, Heterocyclic inhibitor as selective Tyk-2 inhibitor, PCT 2014/0155,398, 2014, Azaindole derivatives as kinase, US 8,076,370, 2011, Antimicrobial agents, PCT 2010/0286,211, 2010, Oxazolidinone as antimicrobials, PCT 2009/0215,764, 2009, Antimicrobial agents

Title: Business Requirement analysis, requirement gathering, Gap analysis, recommend business solution based on Industry Best Practices, deliver client requirement on business solution, create ASIS, To Be document, Demonstrate business use cases and white papers in the domain of Pharma, regulatory, Clinical trial, Pharma ERP software, create User stories, data validation in domain of life science, Pharmacovigilance projects, create dashboard for automation of Pharma, regulatory products.

• Atal Swasthya Samman, Sevron Foundation, 12/01/19, For extraordinary achievement in the field of Healthcare in NCR for the contribution in public health project Medanta Hospital.
• Research Excellence Award, INSC, 01/01/20, For research and development of preclinical and clinical development of drug and discovery of novel disease target in immune-oncology, anti-infective, anti-inflammatory drugs.

• Johnson and Johnson
• ADMA Bio
• QuVa Pharma
• Astellas Pharma
• GSK

• Clinical Research Coordinator, Medanta Hospital, Gurgaon, Haryana, 2017-2019, Coordinated clinical trials., Patient recruitment, screening, consenting for phase three Clinical Trial (Sanofi)., SAE reporting, meeting with Fill form 11 as schedule Y, EC meetings., EDC and Database update for EHR., Trial Master file management., Coordinate in monitoring and audit and IMP accountability.
• Senior Research Scientist, Daichi Sankyo R&D, Gurgaon, Haryana, 2003-2017, Evaluate new projects, analyze feasibility, and propose novel targets in Drug discovery., Present Research plan, progress and risk assessment, predict toxicity, metabolic properties of drugs., Actively engaged and developed many potential preclinical drug candidates in novel targets to combat cross resistance.