Profile Details

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Hire Bicky M.

South Africa

USD 60 /hr

Senior Clinical Trial Project Manager and Senior CRA

Profile Summary

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.

Subject Matter Expertise

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

Services

• 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

Work Experience

Senior Clinical Resource Associate,

PPD, Inc

April 2021 - Present

REGIONAL TRIAL MANAGER

Sanofi

April 2017 - April 2021

LOCAL STUDY MANAGER

Sanofi

August 2014 - March 2017

INVENTIVE HEALTH

Ingenix-i3-InVentiv Health Clinical

January 2012 - July 2014

Senior Clinical Research Associate

Pfizer

July 2011 - December 2011

Clinical Research Associate

Novo Nordisk

May 2008 - June 2010

Clinical Research Associate

Pfier

April 2007 - April 2008

Education

MSc, Medical Pharmacology,

Sefako Makgatho University

January 2012 - December 2014

MSc, Project Management (MPM)

University of Pretoria

January 2010 - December 2012

BSc (Hons), Biochemistry,

Sefako Makgatho University (SMU),

January 2005 - December 2005

BSc, Physiology & Psychology

University of Limpopo, Medunsa campus

January 2000 - December 2004

Certifications

• Good clinical practise

  Wits Health Consortium

  April 2021 - April 2021