Priya Vaswani

About Priya Vaswani

I am a skilled and passionate professional with over 8 years’ experience in the health care and pharma sector, strategizing, developing and implementing processes and procedures that generate efficiencies and streamline workflows across an enterprise. My expertise includes clinical and market research, clinical trial & project management, data analysis, development and implementation of QMS, training program development, virtual and classroom training, and small-scale business management. I possess proficient scientific, clinical and TA, FDA, ICH & GCP regulation, and IPHA code knowledge. I have immense auditing experience through facing external audits by INAB (Irish National Accreditation Board) and conducting regular internal quality and technical audits in an ISO 15189 Medical Testing Laboratory. I also carry a deep passion for outreach programs and endeavor to work more in this area in the future.

Experience

1. Lab Study Manager

   GSK

   Jan 2023 — Present · Bengaluru, IN

   Conducted operational set-up & follow-up of all laboratory related activities for Vaccine Clinical Trials aligning with all key stakeholders in Clinical Operations to support delivery of clinical results timely at right quality and cost.• Clinical Trial Supplies set-up and management in conjunction with Central Lab/Internal Teams to ensure timely initiation of trials.• Monitoring trial related activities to provide management with consolidated information on central laboratory, sample management, data delivery, budget review & annual forecast as well as key performance indicators to surface issues.• Define the operational set-up to align bio specimen flows, testing activities and data flows for each clinical trial and assure it is in line with the other key stakeholder’s constraints.• Provide input in development of study protocol and related documents and establish the operational feasibility of each new study protocol.• Be the human bio specimen custodian for the study, from study start to study end as per statutory guidelines.• Worked on initiatives to support hyper acceleration of LSLV to DBL with management.• SME for eTMF Support and Management activities across the department.• Author for end to end Department SOP in collaboration with senior Leadership as part of the Written Standard Simplification Process.

Education

• Jyoti Nivas College Autonomous, Bangalore

  Bachelor of Science (BSc), Biotechnology

  2006 — 2012

• Mount Carmel College

  Master of Science (MSc), Biotechnology

  2012 — 2014