Sriram Murthy Kothari He

About Sriram Murthy Kothari He

A seasoned Clinical Research professional with around 22 years of experience spread across Global Clinical Operations, Clinical Project Management and R&D Project Management.Always thirsty to work for Medical Devices, Pharma - Clinical AI / Healthcare Digitization, Pharmacovigilance, FMCG, Nutraceuticals and Public health for social cause.Key professional achievements include:• Played a pivotal role in successfully setting up a Bio-equivalence Center.• Was instrumental in successfully executing the first clinical bio study at a new Bio-equivalence center.• Provided Project Management Support for more than BE studies for Domestic and International Clients.• Extensive experience on First to File (FTF), Respiratory Products (DPI and pMDI Inhalers), Transdermal patches and NCE-1 submission for Generics.• Very effective in end to end Clinical Project Management.• Exceptional in preparing project metrics, organizing project meetings, taking project minutes, project follow up and closure of action items.• Gained significant experience in developing SOP and compliance systems.• Gained working knowledge of International and local regulatory guidelines like US FDA, EMEA, ANIVSA, ICH/GCP guidelines, Indian Schedule Y (DCGI), FSSAI for clinical studies.• Abundant monitoring and project management experience in Clinical Phase studies.• Significant experience in setting up of study specific Central Laboratory databases.• Successfully faced Regulatory inspections from US FDA, EMEA, ANVISA, Health Canada and others.• Handled, mentored, monitored and appraised team sizes ranging from 6 to 80, as a part of various project specific assignments.• Very flexible in working with diverse geographical cultures / teams and very familiar in working across different global time zones.• Summarizing the top Management on project status reports, project achievements, capacity utilization and budget monitoring.

Experience

1. Senior Clinical Trial Manager

   Tech Observer

   Oct 2021 — Present · Mumbai, IN

   FSP (Full time equivalent) for Abbott Global.Handling of Abbott Global clinical projects for BA/BE and Co-development projects for Branded Generics.Responsible for:• End to End operational execution of assigned assigned clinical projects (Interventional & Non-Interventional Clinical Studies)• Global Clinical Trial Management• Global Project Management• Internal and External Stakeholder Management• CRO/Vendor Management• Quality Metrics and Clinical Governance• As Chair of the study, update progress to Management in Clinical governance and Medical Office Governance meetings• Support and participate in the preparation and execution of internal audit or external inspection• Lead Risk and Issue Management • Contribute for continuous process improvement increasing efficiency of Clinical Operations and project quality

Education

• Osmania University

  B. Pharmacy, Pharmaceutical Sciences

  1998 — 2002

• ISBM, Hyderabad

  Master of Business Administration (M.B.A.), Clinical Research Management

  2013