Supriya Soni
Senior Central Monitoring Manager at Johnson & Johnson, IDAR India Hub
- Role
- Senior Central Monitoring Manager at Johnson & Johnson
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Supriya Soni
Strategic leader in global clinical operations and risk‑based monitoring, bringing 11+ years’ experience designing and operationalizing CtQ, KRI, and Quality Tolerance Limits (QTLs) frameworks. Subject matter expert (SME) in Analytical Risk‑Based Monitoring (ARBM), risk-based data management (RBDM), and site monitoring. Currently serving as Senior Central Monitoring Manager at Johnson & Johnson IDAR (Oncology), accountable for designing and executing central monitoring and RBDM activities across multiple global Phase trials in alignment with ICH‑GCP and applicable regulations. Also, a RBDM SME with deep expertise in KRI governance, QTLs, risk assessment and mitigation, and development of SOPs, templates, and job aids; skilled at converting dashboard‑driven analytics into actionable oversight, leading cross‑functional stakeholder engagement, and training teams to enhance data quality and inspection readiness. Therapeutic Area Exposure: Oncology (Hematology & Solid tumor), Immunology (Crohn’s Disease), Vaccines (COVID-19, H1N1), Neuroscience (MS, Alzheimer), Cardiovascular (Hypertension), Respiratory (Asthma)She is a graduate of Healthcare Businesswomen’s Association (HBA)- Global Ambassador Program at Johnson & Johnson. She has completed Women Wizards Rule tech (W2RT) training program - a unique program launched under the NASSCOM D&I Initiative designed exclusively for Women professionals at IQVIA.Supriya is passionate about reading novels & travelling.Specialties: Risk Based Data Management, Central Monitoring, Data Analytics, GCO functional management, compliance management, clinical project delivery, and quality oversight
Experience
Senior Central Monitoring Manager
Sep 2024 — Present · Mumbai, IN
Lead end-to-end risk-based monitoring for 3 complex global trials (setup, execution, close-out) by managing a diverse team across multiple geographies and serve as SME for RBDM training & developing templates, SOPs, and job aids.· Optimize analytics and study reports to identify trends and site outliers; implement CAPA and site mitigation plan for persistent outliers and train CRAs on KRI/CtQ reviews.· Partner cross-functionally and facilitates smooth and effective communication, managing multiple communication streams and influencing key cross functional stakeholders to resolve critical issues and improve compliance. · Provide oversight and evidence for site/program audits and regulatory inspections, and support remediation activities as required. · Supports innovation or process improvement projects related to programming of reports, user acceptance testing and identification of improvements to existing and new analytical tools. · Onboarding buddy and mentor for interns and new hires, guiding them in ARBM processes and ways of working.
Education
Bioinformatics Institute of India (BII), Noida
PGDRA (Post Graduate Diploma in Regulatory Affairs), Regulatory Affairs
2013 — 2014
Anand Pharmacy College
Bachelor's Degree, Pharmacy
2008 — 2012
M.S.University Vadodara
M.Pharm, Pharmaceutical Quality Assurance
2012 — 2014
Skills
- Biotechnology
- Regulatory Affairs
- Spectrofluorimeter
- Dsc
- Sigmaplot 12.0
- Uv Probe 2.34
- Science Direct
- Sci Finder
- Double Beam Uv-Visible Spectrophotometer
- Powerpoint
- Microsoft Excel
- Graphpad Prism5
- Ipr
- Dissolution
- Hplc
- Teamwork
- Design Expert Software (Doe)
- Ir
- Pubmed
- Lyophilizer
- Dissolution Apparatus
- Quality Assurance
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