Rakesh Somashekaraiah

PhD Microbiology | Laboratory Support Services | Vendor Management | Project Management

Role
Laboratory Specialist at PSI CRO
Location
Bengaluru, KA, IN
LinkedIn followers
500 followers

About Rakesh Somashekaraiah

Laboratory management, with PhD in Microbiology. I play a key role in the qualification…

Experience

  1. Laboratory Specialist

    PSI CRO

    Mar 2024 — Present · Bengaluru, IN

    Project Management- Vendor Management Study related activities (Laboratory Support):• Review of study documents• Contribute to the development of diagnostic strategies, including the development and review of assay validation plans and reports• Document and drive the Laboratory Strategy• Present laboratory strategy at kick-off meetings• Support the selection of central and regional laboratories for studies• Perform qualification of off-site / on-site laboratories for a study• Coordinate the contracting of central / regional / off-site laboratories• Perform central / regional / off-site laboratory set up• Contribute to Risk Management process• Provide information to PSI Data Management(DM) to aid eCRF design• Deliver training to the study team and/or clinical sites in laboratory related procedures• Perform initiation and monitoring visits to laboratories as required• Coordinate routine calls with central laboratories• Attend study progress calls with the Sponsor• Provide support / consultancy to Sponsor / PSIteam for all laboratory related issues• Investigate issues with laboratories / couriers / sites• Coordinate the transfer of samples between laboratories• Assist DM in on-going data reconciliation• Coordinate any changes to the laboratory strategy• Perform close out of central / regional off-site• Develop and/or implement operational (project specific and laboratory specific) quality control documents• Participate in system audits and follow up on audit findings related to laboratories that provide testing for the assigned projects

Education

  • Sri Bhagawan Mahaveer Jain College

    Bachelor of Science (B.Sc.)

    2007 — 2010

  • University of Mysore

    Doctor of Philosophy - PhD

    2017 — 2023

  • Vellore Institute of Technology

    Master of Science (M.Sc.)

    2010 — 2012

Skills

  • Biotechnology
  • Quality Control
  • Gmp
  • Environmental Monitoring
  • Microbiology
  • Pharmaceutical Industry
  • Pcr
  • Molecular Biology
  • Leadership
  • Cell Culture
  • Life Sciences

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Rakesh Somashekaraiah — Laboratory Specialist at PSI CRO in Bengaluru, KA, IN | Unifers