Clinical Project Management


Category:  Clinical Trial - Advanced courses ,
Management
Lecturer: Dr Stanley Garbus
 
Course Language: English
Course Name: Clinical Project Management
Duration: 2 - Day Course
Date: March 8,9 2011
Hours: 9:00am - 5:00pm
Registration: 8:30am
Location: Corporate College East 4400 Richmond Road Warrensville Heights, OH / On Site
Price:  Basic Price: $595/day, Early bird registration- $495/day
Course ID : A10174

Registration Form
A well-managed clinical trial can lead to reduced product approval time, decreased development costs and acceleration of the product approval leading to earlier initiation of the revenue stream. This comprehensive training program provides the essentials of clinical trial project management: how to create a project team; develop project objectives, plans and timelines; and to effectively implement, monitor and control clinical projects. The course begins by describing the basic fundamentals and pharmaceutical industry standards of project management techniques. Details are presented for understanding clinical trial costs and developing timely budgets to create successful study completion on budget. Participants learn skills of leadership, negotiation and communication that will positively impact the success of clinical projects. Important other discussions clarify processes for managing project deliverables, improving patient recruitment practices and ensuring compliance with regulatory requirements. At the completion of this two-day course, participants will have learned regulatory requirements for clinical trial management, concepts of project management and skills to direct the development team, master time management, identify potential conflicts and utilize high-value problem-solving techniques. As professionals learn in different ways, often defined by the focus of their responsibilities, the course employs adult learning principles that include: education that addresses actual issues, knowledge enhanced through reinforcement and the transfer of learning through real-world examples and hands-on workshops. Thus, the course combines lecture with interactive discussions and exercises to ensure participants return to their jobs equipped with practical knowledge and skills to enhance clinical trial management.
Benefits to the Participants
  • Practice cross-functional project management to ensure project success through formation of a cohesive project team
  • Assemble and lead the clinical trial team and conduct effective team meetings to model good communication practices throughout the trial
  • Develop project objectives and a project plan to keep team members well organized and on target
  • Develop a realistic timeline to track progress against set objectives
  • Develop contracts and subject enrollment strategies to minimize costs and stay on budget
  • Implement, monitor and control projects to enable an on-time, on-budget project completion
  • Communicate with internal and external stakeholders and avoid communication breakdowns that can lead to project delays
  • Utilize proven audit techniques to establish a practical approach for maintaining regulatory compliance
  • Implement best practices for managing misconduct and fraud to protect patient safety and avoid costly regulatory and legal action
  • Develop efficient processes for data management and adverse event reporting
  • Utilize proven quality control tools to collect and measure performance data and implement process improvements
Issues to be covered
  • The drug development process, clinical trial designs, drug review, approval
  • Clinical Project Team responsibilities
    • Develop project objectives
    • Identify strengths and opportunities
    • Develop and lead the Project Team
  • Key responsibilities of a Clinical Project Manager
  • Team member responsibilities during clinical trials
  • Create a clinical trial timeline
  • Create a Project Plan: activities, resources, risks
  • Study start-up and negotiating clinical trial contracts
  • Financial management of a clinical trial: project budgets, tracking system
  • Project implementation, monitoring and control
  • Preventing and detecting fraud
  • Regulatory Agency audits
  • Subject enrollment strategy
  • Conduct effective team and Investigator meetings
Who should attend
Pharmaceutical and Biotechnology personnel: Clinical Research Associates, Clinical Project Managers, Clinical Research Managers, Clinical Operations staff, Clinical/Medical Research Scientists, Quality Assurance Managers, Data Managers, GCP Managers/Auditors, Research Nurses
About the Speaker
Dr. Stanley Garbus has extensive pharmaceutical industry experience across all phases of clinical research and pharmacovigilance, including development and implementation of AE safety systems. He is Cofounder and Chief Medical Officer of Sentrx, a company that supports the pharmaceutical industry in monitoring clinical and postmarketing adverse events, improving drug safety and assisting with risk management.
Previously, Dr. Garbus held senior clinical research management positions in several international pharmaceutical companies and Contract Research Organizations. He received his medical degree from the University of Geneva, Switzerland, completed specialty training in Internal Medicine and Nephrology and received a Master’s in Public Health in Epidemiology from the Yale University School of Medicine.
Dr. Garbus has lectured, led workshops, chaired conferences and provided in-house industry staff training in the US, Canada, Europe and Japan on Crisis Management and Product Liability, Clinical Project Management, Pharmacovigilance and Risk Management. He has presented the Pharmacovigilance/Safety Surveillance Tutorial for the annual meeting of the US Drug Information Association for the past seven years, lectured at the Canadian Drug Information Association and was Program Chairman for an annual meeting of the American Academy of Pharmaceutical Physicians.  He is the author of peer-reviewed scientific articles and on-line educational programs on pharmacovigilance.

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