プロフィール詳細

プロジェクトを作成

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Keshini S.に依頼

Sri Lanka

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

プロフィール概要

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.

専門分野

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

サービス

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

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

職務経験

Project Lead - Clinical Operations

RemediumOne Pvt. Ltd.

1月 2018 - 11月 2020

Study Lead - Clinical Operations

RemediumOne Pvt. Ltd.

1月 2017 - 1月 2018

External Consultant - Pharmacovigilance

IQVIA

11月 2016 - 1月 2017

Senior Clinical Research Coordinator

RemediumOne Pvt. Ltd.

1月 2016 - 12月 2016

Clinical Research Coordinator

RemediumOne Pvt. Ltd.

11月 2014 - 12月 2015

Project Assistant

World Class University Project, University of Sri Jayewardenepura

7月 2013 - 10月 2014

Graduate Research Assistant

Genetic Diagnostic and Research Laboratory, University of Sri Jayewardenepura

9月 2012 - 10月 2014

学歴

Master of Business Administration

University of Wales Trinity Saint David

1月 2018 - 11月 2019

Bachelor of Science - Medical Bioscience

Monash University

3月 2009 - 3月 2012

認定資格

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

  Brookwood International Academy

  11月 2015 - 現在