12 Essential Activities of Clinical Trial Project Management: guide to successfully manage a clinical trial project - Paperback

by T. C. George (Author)

The book includes 12 essential activities undertaken by a project manager which includes Project Milestones Planning and Forecasting, Cost Estimate and Financial Planning, Logistics Planning, Vendor Selection and Management, Creation of Trial Master file, Management of Regulatory Document Submission, Co-ordination of Individual Site Set-up Activities, Import Export Requirements for Clinical Trials, Organization of Investigator Training Meeting, Study Initiation, Conduct and Milestones Tracking, Audit(s) and Quality Assurance, Regulatory Inspection, Study Closeout: Trial Completion, Suspension, Termination.

Author Biography

With the accomplishment of PhD and Masters in Pharmacy, Dr T C George has been engaged in clinical trial operations for more than 12 years. He has been a part of more than 100 clinical trials on various positions. He started his career as Clinical Trial Coordinator and then appraised to as Clinical Trial Monitor in a short span of time. For a long time he worked as a freelancer for various Sponsor and CROs as a Clinical Trial Monitor. Presently he is working as Project Manager and working on various therapeutic areas of clinical studies. He has won several awards and recognition for his work and dedication. To uplift the clinical research community, he has participated in various domestic and international forums & discussion to share his experience and knowledge.