プロフィール詳細

プロジェクトを作成

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Bicky M.に依頼

South Africa

Senior Clinical Trial Project Manager and Senior CRA

プロフィール概要

With over 15 years of experience in clinical research in different positions, including CRA, Regional Study Manager, Local Study Manager, Study-start-up Specialist, and Regulatory Specialist. As CRA worked on more than 15 clinical trials in different Therapeutic areas and gained significant experience in Diabetes Mellitus Types I and II. Performed Feasibility and all types of on-site and remote Monitoring Visits: PSV, SIV, IMV and COV with 100% or reduced SDV and rSDR. As Regional and Local Study Manager, clinical study monitoring oversight and project management on phase II-III studies, from feasibility to Clinical study report in Asthma, DM I&II, cardiovascular diseases. As Study Start-Up Specialist, responsible for study set-up, regulatory & submissions for oncology studies, phase I/II-IV. Provided on-site monitoring support for lung cancer and multiple myeloma studies. As a Regulatory Specialist coordinated regulatory activities, review new clinical trial applications for multiple therapeutic areas.

専門分野

• ★ Clinical Trials
• ☆ Medical Sciences
• ☆ Product Compliance

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research User Research, Feasibility Study, Systematic Literature Review

Consulting Regulatory Consulting

Product Development Prototyping

職務経験

Senior Clinical Resource Associate,

PPD, Inc

4月 2021 - 現在

REGIONAL TRIAL MANAGER

Sanofi

4月 2017 - 4月 2021

LOCAL STUDY MANAGER

Sanofi

8月 2014 - 3月 2017

INVENTIVE HEALTH

Ingenix-i3-InVentiv Health Clinical

1月 2012 - 7月 2014

Senior Clinical Research Associate

Pfizer

7月 2011 - 12月 2011

Clinical Research Associate

Novo Nordisk

5月 2008 - 6月 2010

Clinical Research Associate

Pfier

4月 2007 - 4月 2008

学歴

MSc, Medical Pharmacology,

Sefako Makgatho University

1月 2012 - 12月 2014

MSc, Project Management (MPM)

University of Pretoria

1月 2010 - 12月 2012

BSc (Hons), Biochemistry,

Sefako Makgatho University (SMU),

1月 2005 - 12月 2005

BSc, Physiology & Psychology

University of Limpopo, Medunsa campus

1月 2000 - 12月 2004

認定資格

• Good clinical practise

  Wits Health Consortium

  4月 2021 - 4月 2021