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
Laboratory Specialist
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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