Project Management of Clinical Studies

    /Richard L  /Chamberlainspeaker of Training Doyensinvite
    Speaker: Richard L Chamberlain


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    Duration: 90 Minutes
    Product Code: 50339
    Level: Intermediate

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OVERVIEW

  • State of the industry
  • Initiating projects
  • Planning projects
  • Resources
  • Dates
  • The management of Phase I through Phase IV
  • Executing and controlling
  • Risk management and Quality Management
  • Project team dynamics
  • Closing Projects

WHY SHOULD YOU ATTEND

This online training course will focus on the basic principles of project management and how they can be applied to best meet the needs of your clinical trials.  You will take away a set of project management skills and techniques that can be immediately put to use.

This is designed for biotechnology/pharmaceutical/medical device professionals who are involved managing clinical trials and are looking to learn more about the basic project management process and how it might apply to their tasks.

AREAS COVERED

  • The Role of the Required Documentation
  • The Management of Dates and Resources
  • The use of Excel and MS Project
  • The Role of SOPs in the Preparation and Management of that Documentation.
  • The organization of Processes and Sub-Processes.
  • How to use Quality Management and Risk Management.
  • The Content and Format of SOPs.

LEARNING OBJECTIVES

At the conclusion of this course, participants should be able to:

  • Define clinical project management
  • Plan the work
  • Estimating Dates
  • Produce the schedule
  • Work in teams
  • Forecast a clinical trial budget
  • Execute and control the clinical plans
  • Close the project

WHO WILL BENEFIT

  • Project Managers who manage Clinical Trials
  • Financial Staff
  • Operation managers and staff
  • Auditors
  • Compliance Professionals
  • Project practitioners
  • Quality Assurance Professionals

SPEAKER

Years of Experience: 20+ years

Areas of Expertise: Strategic Planning, Quality Management and Computer Systems Validation

Richard Chamberlain's experience includes consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.

Apart from these Mr Chamberlain has taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems; assisted in the development and validation of numerous computerized systems in all GxP environments; assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations. He is also familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs.

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