Profile Details

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Hire Keshini S.

Sri Lanka

USD 45 /hr

Freelance clinical research professional with eight years of experience; BSc. in Medical Bioscience and an MBA

Profile Summary

From initially coordinating and ultimately supervising Phase IIb and III clinical trial protocols sponsored by pharmaceutical organizations such as Gilead Sciences, Sanofi, George Clinical, Aurinia Pharmaceuticals, Boehringer Ingelheim, and Merck & Co. under Gastroenterology, Cardiology, Nephrology, Neurology and Endocrinology related specialties being conducted at a national level across public sector hospitals in Sri Lanka; I not only have exposure to the technical aspects of clinical research management from startup to implementation and close-out, but also to several administrative components that included drafting project related SOPs and updates, presenting and discussing project updates and risk management with stakeholders, monitoring and evaluation of research activities, and, procurement and logistics management to ensure and maintain the quality and deliverables of the study are maintained as per the regulatory standards. Having completed my BSc. in Medical Bioscience in 2012, I have also completed my Project Management coursework in 2018, and, an MBA in 2019, to further complement my work experience and broaden my knowledge, scope, and, thought process in terms of effective and efficient oversight and management of clinical trials in Sri Lanka.

Subject Matter Expertise

• ★ Clinical Trials
• ★ Pharmacovigilance/Drug Safety Monitoring
• ☆ Biology/Life Sciences
• ☆ Data Management
• ☆ Neurology
• ☆ Gastroenterology & Hepatology
• ☆ Endocrinology
• ☆ Cardiovascular Disease
• ☆ Managed Healthcare
• ☆ Technical & Scientific Writing
• ☆ Language Translation

Services

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Work Experience

Project Lead - Clinical Operations

RemediumOne Pvt. Ltd.

January 2018 - November 2020

Study Lead - Clinical Operations

RemediumOne Pvt. Ltd.

January 2017 - January 2018

External Consultant - Pharmacovigilance

IQVIA

November 2016 - January 2017

Senior Clinical Research Coordinator

RemediumOne Pvt. Ltd.

January 2016 - December 2016

Clinical Research Coordinator

RemediumOne Pvt. Ltd.

November 2014 - December 2015

Project Assistant

World Class University Project, University of Sri Jayewardenepura

July 2013 - October 2014

Graduate Research Assistant

Genetic Diagnostic and Research Laboratory, University of Sri Jayewardenepura

September 2012 - October 2014

Education

Master of Business Administration

University of Wales Trinity Saint David

January 2018 - November 2019

Bachelor of Science - Medical Bioscience

Monash University

March 2009 - March 2012

Certifications

• Certificate in Essential Good Clinical Practice (ICH-GCP)

  Brookwood International Academy

  November 2015 - Present