Bhupendra Sharma

About Bhupendra Sharma

Curious senior leader who is open to learn, willing to take new challenges, result oriented and passionate to deliver value for business and people• 17+ years of experience in drug and device development and patient care, specialized in Global Clinical Operations and Project Management, spearheading business growth in clinical services, contributing to business strategy and its operationalization, business transformation and new engagement models • Proven track record of building and leading multi-site diverse teams (max. up to 55 associates) of talented 1st line people managers, clinical program leads, clinical project managers, clinical operations specialists, central data monitoring experts, digital endpoint experts, clinical research associates, clinical research coordinators and clinical trial assistants contributing to: Clinical studies (interventional / non-interventional) with or without remote (decentralized) trial solutions, green initiatives and digital endpoints Research collaborations (RCs), Investigator initiated trials (IITs), Managed access programs (MAPs), Central data monitoring, Clinical site monitoring and Clinical site management • Responsible for operational & quality excellence and timely delivery by the team on agreed projects, set-up of required governance structure / review boards and escalation matrix• Shouldered increasing roles & responsibilities in clinical study domain which helped in acquiring knowledge of study management from different aspects• Exposed to interventional (phase II to IV) and non-interventional clinical studies of different therapeutic areas (e.g. Oncology, Hematology, Cardiology, Nephrology, Urology, Immunology, endocrinology, community disease etc.) in various capacities • Hands on with process development / optimization and navigating through business transformations• Key achievements are - delivery of complex clinical projects, navigating self & team through business transformations, establishment of a new team and business expansions

Experience

1. Head (Director) - Clinical Project Management

   Novartis

   Sep 2021 — Present · Hyderabad, IN

   Roles in team: Group Leads, Clinical Program Leads, Digital Endpoint Experts, Clinical Project Managers, Clinical Operations Specialists and Central Data Monitoring ExpertsAverage team size:~50 Location of team: Hyderabad, Kuala Lumpur and BeijingProjects team involved: Interventional clinical studies, NIS, RCs, IITs, MAPs and central data monitoring projectsKey deliverables: • Account management for clinical services to Novartis business units• Responsible for operational & quality excellence, timely delivery by team on agreed projects, set-up of required governance structure / review boards and escalation matrix• Responsible for business continuity and contribute to business development• Drive productivity through robust demand - capacity planning and optimal resource utilization, part of department level cross site resource taskforce • Drive positive P&L; keep track of revenue against headcount• Lead & maintain a diverse team, provide opportunities for development and growth• Ensure hiring of new talent as needed and implement retention strategies • Support process development and optimization e.g. new ways of working, competency framework and harmonization of NIS processes • Contribute to annual business strategy planning & refresh

Education

• National Institute of Management, Ahmedabad

  Master of Business Administration (MBA), Operations Management

  2006 — 2008

• Ahmedabad Homoeopathic Medical College

  Bachelor of Homoeopathic Medicine and Surgery (BHMS), Medicine

  2000 — 2006

Skills

• Pharmacovigilance
• Regulatory Requirements
• CRO
• Oncology
• Protocol
• Regulatory Affairs
• Clinical Monitoring
• Ich-Gcp
• Clinical Development
• Biotechnology
• Clinical Trials
• Clinical Research
• Fda
• Clinical Data Management
• Oracle Clinical
• Good Clinical Practice (Gcp)
• Edc
• Ctms
• Gcp