Bhuvaneshwari Jamindar Ganesh

About Bhuvaneshwari Jamindar Ganesh

Senior Leader in Clinical Data Management with 12+ years of experience driving global…

Experience

1. Senior Manager, Global Clinical Development Operations

   Bristol Myers Squibb

   Oct 2022 — Present · US

   Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects• Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members• Provides strong quality and project oversight over third party vendor responsible for data management deliverables• Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway)• Enforces data standard conventions and quality expectations for clinical data per defined processes• Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization• Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness• Represents DM on cross-functional project teams & submission Teams• Lead or support the Health Authority inspections and audits• Provides coaching and quality oversight of junior Data Management Leads• May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)• Continuous improvement initiatives• Provides the relevant support and input to continuous improvement activities within clinical data management• Provides support for CAPA implementation as required

Education

• Sri Ramachandra Institute Of Higher Education and Research

  Doctor of Pharmacy - PharmD

• St. Cloud State University

  Master of Science - MS