Sridhar S B

Experience

1. Head of Clinical Research

   USV PRIVATE LIMITED

   May 2021 — Present · Mumbai, IN

   In charge of Clinical Research Department,Responsible for outsourcing of entire clinical research activities, Medical affairs, strategy for new product development including bio-similar, clinical rationale for new product including market analysis. Involved in planning and conducting clinical research studies.Primary contact person between USV and CROs, responsible for Clinical Development Plan and outsourcing, Well versed with the Outsourcing processes.Time lines generation and Follow up over R&D activities to ensure smooth running of subsequent operations, data flow.Prepare and review of Clinical Budgets/Pricing/Quotes including management of clinical study conduct.Negotiation of Quotes with CRO’s for best pricing.Review CDAs, MSAs.Initiation, Planning, Site selection, Management of clinical study conduct in Various CRO’s.Planning DCGI- BENOC and Import license activities for pipeline products and repeat studies.Providing strategic leadership to the team members.Fixing the targets to team members supporting to complete their targets as per allocated timelines.Participate in R&D project team meetings and present status update on all operational aspects of clinical trials.Managed multiple projects at a time.Interacting with project managers, Regulatory authorities, with questions and concerns related to the conduct of the Clinical trials, Regulatory aspects, Controlled communications and responding to queries.

Education

• Manipal Academy of Higher Education

  MD (pharamacology)

• CATALYST INSTITUTE OF MANAGEMENT AND ADVANCE GLOBAL EXCELLENCE

  PCPV