Shilpi Sinha work email
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Shilpi Sinha personal email
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• A Clinical Research Professional with over 12 years’ experience, with 2 years as India lead inclinical operations with responsibilities of both functional and Line management, 8 years in Project & Quality Management and 4 years of clinical monitoring experience as a CRA in global multinational studies• International project experience in working & managing Oncology, Virology, Cardiology, Bipolar and Anti –Infective trials in India and across Central and Eastern Europe and South Africa; responsibilities have spanned the full duration studies, from start up to project close out.• Managed Customers and Vendors in terms of development of contracts and MSAs and ensure contractual obligations are met, developed different geographies and successful in implementing metrics for tracking KPIs. • Experience in managing the Kaizen events for Pharmacovigilance, Tracking of safety reports and responding to Health Authorities queries with PV team.• Hands-on experience in clinical management while adhering to strict guidelines and processes; achieving benchmarks in clinical dispensing, improving processes and driven by a passion for achieving high quality at work.
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Director, Country Head Rco IndiaBristol Myers Squibb Nov 2024 - PresentLawrence Township, Nj, Us -
Associate Director, Country Head Rco IndiaBristol Myers Squibb May 2023 - Nov 2024Lawrence Township, Nj, Us -
Lead - Regional Clinical Operations, IndiaBristol Myers Squibb Apr 2017 - May 2023Lawrence Township, Nj, Us -
Senior Project Manager & Quality SpecialistBristol Myers Squibb Jul 2013 - May 2023Lawrence Township, Nj, UsIn my project management and Quality Specialist capacity, I am currently responsible for Asia (India, Korea, Singapore, Hong Kong,Thailand and Taiwan since Jan 2015 (earlier China as well). -
Senior Site ManagerBristol Myers Squibb Jan 2012 - Jun 2013Lawrence Township, Nj, Us -
Project Quality LeadParexel Apr 2010 - Dec 2011Durham, North Carolina, UsProvide Quality oversight to Project team throughout the Project life-cycle. • Implement the standard quality interventions for assigned projects, verifying compliance with GCP guidelines/regulations, organization procedures and requirements, and sponsor requirements.• Review key project documentation and provide feedback to the project team.• Actively participate in key internal project team meetings and facilitate quality discussions during these meetings. -
Clinical Team LeadQuintiles Oct 2004 - Apr 2010Durham, North Carolina, UsAlmost six years of work experience in Clinical Research with 4 year of clinical monitoring experience as a CRA in global multinational studies (Phase I, II and III). Experience in managing studies in Oncology, Bipolar diseases, Cardiology, and Anti -Infective as a Clinical Team Leader. Experience of leading Clinical team or teams of a given project and projects by giving direction and co-ordination all activities in order to ensure that a contracted project is initiated, conducted and completed within predetermined timelines as per agreed SOPs in compliance to GCP.
Shilpi Sinha Skills
Shilpi Sinha Education Details
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Kasturba Medical College, MangaloreMedical Biochemistry -
Delhi UniversityChemistry (Hons)
Frequently Asked Questions about Shilpi Sinha
What company does Shilpi Sinha work for?
Shilpi Sinha works for Bristol Myers Squibb
What is Shilpi Sinha's role at the current company?
Shilpi Sinha's current role is Director, Country Head RCO India.
What is Shilpi Sinha's email address?
Shilpi Sinha's email address is sa****@****ail.com
What schools did Shilpi Sinha attend?
Shilpi Sinha attended Kasturba Medical College, Mangalore, Delhi University.
What skills is Shilpi Sinha known for?
Shilpi Sinha has skills like Project Management, Gcp, Clinical Monitoring, Oncology, Clinical Research, Clinical Operations, Ich Gcp, Cro, Ctms, Edc, Clinical Trials, Quality Assurance.
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