Shilpi Sinha

Shilpi Sinha Email and Phone Number

Director, Country Head RCO India @ Bristol Myers Squibb
Shilpi Sinha's Location
Mumbai, Maharashtra, India, India
Shilpi Sinha's Contact Details

Shilpi Sinha work email

Shilpi Sinha personal email

About Shilpi Sinha

• 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.

Shilpi Sinha's Current Company Details
Bristol Myers Squibb

Bristol Myers Squibb

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Director, Country Head RCO India
Shilpi Sinha Work Experience Details
  • Bristol Myers Squibb
    Director, Country Head Rco India
    Bristol Myers Squibb Nov 2024 - Present
    Lawrence Township, Nj, Us
  • Bristol Myers Squibb
    Associate Director, Country Head Rco India
    Bristol Myers Squibb May 2023 - Nov 2024
    Lawrence Township, Nj, Us
  • Bristol Myers Squibb
    Lead - Regional Clinical Operations, India
    Bristol Myers Squibb Apr 2017 - May 2023
    Lawrence Township, Nj, Us
  • Bristol Myers Squibb
    Senior Project Manager & Quality Specialist
    Bristol Myers Squibb Jul 2013 - May 2023
    Lawrence Township, Nj, Us
    In 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).
  • Bristol Myers Squibb
    Senior Site Manager
    Bristol Myers Squibb Jan 2012 - Jun 2013
    Lawrence Township, Nj, Us
  • Parexel
    Project Quality Lead
    Parexel Apr 2010 - Dec 2011
    Durham, North Carolina, Us
    Provide 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.
  • Quintiles
    Clinical Team Lead
    Quintiles Oct 2004 - Apr 2010
    Durham, North Carolina, Us
    Almost 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

Project Management Gcp Clinical Monitoring Oncology Clinical Research Clinical Operations Ich Gcp Cro Ctms Edc Clinical Trials Quality Assurance Sop Cardiology Capa Oracle Clinical Regulatory Submissions Clinical Development Program Management Client Focused Approach To Work Drug Development Project Initiation Regulatory Audits Inspection Good Clinical Practice

Shilpi Sinha Education Details

  • Kasturba Medical College, Mangalore
    Kasturba Medical College, Mangalore
    Medical Biochemistry
  • Delhi University
    Delhi University
    Chemistry (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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