Strategic Clinical Project Management: Principles and Practical Applications
In the project management world, there are resources to help you manage almost any project. There are many processes, forms, and computer applications that will help you complete your project. But what is the best way to use these tools? What is the order that would make them most impactful? More specifically, how do you apply these tools to a clinical trial environment, where the goals and expected outcomes are much different and risks of failure are much higher?
The answer to these questions and more lies in being strategic. A review of case studies from failed clinical projects shows that the most costly decisions happen at the beginning. When you strategize and keep the most critical factors in mind, you will set yourself up for greater success, and this session will start you on that path.
In this interactive, 90-minute course, you will learn:
- The five key differences between clinical project management and general project management: implementing key steps to ensure success
- Project initiation: Ask the “4 Critical Strategic Questions”
- The definition of strategic project management – are you a strategic or tactical project manager?
- Leadership, strategy and oversight: learn the three domains of strategic project management
- Project maintenance: why risk management, team building, and team leadership are so critical
- Project closure: measure success with definable outcomes and data
This course will be of benefit to anyone involved in single project or program management on a global or domestic scale. Additionally, this course is designed to provide practical tips to those who need to be able to lead a cross-functional project management teams in order to implement clinical trials.
Lydia Dyett joined Halloran Consulting Group in 2013. She has more than 17 years of experience in drug research and development, specifically focusing on cardio-renal and oncology indications from both the CRO and Sponsor side of clinical development. Lydia’s most recent trial experience has afforded her experience in international clinical development and pediatric medicine.
Prior to joining Halloran, Lydia worked primarily in pain, gastro-intestinal and cardio-renal therapeutic areas. She helped adapt new patient reported outcome solutions in OBD and hyponatremia. Working with subject matter experts in regulatory and PRO solutions, Lydia aided in the development of Clinical Global Impression (CGI) scale for dilutional hyponatremia. Lydia also worked on novel research in atrial fibrillation, aiming to integrate 24-hour Phase 1 trial procedures into a standard of care paradigm that releases patients from treatment within 2-hours.
Lyn Agostinelli joined Halloran Consulting Group in 2010. She is a clinical research professional with over 27 years of experience in the industry. She has extensive experience working with pharmaceutical and device companies, proven clinical and project management skills in both academic and industry settings, as well as experience in the development and updating of Standard Operating Procedures to align with best practices and all applicable regulations.
Lyn’s diverse therapeutic experience background includes cardiology, neuromodulation, asthma/allergy, Duchenne muscular dystrophy, hereditary hemophilia and diabetes.
Prior to joining Halloran, she was a Site Manager at Boston Scientific where she developed a remote monitoring group and managed the CRAs performing those activities. In addition she led a cross-functional team of manager and director level staff to align clinical processes with a quality master plan. Prior to Boston Scientific, Lyn was a Clinical Affairs Manager at AAIPharma and oversaw the day to day activities of Research Associates and CRAs. At AAIPharma she also held interim project management roles ensuring projects were executed on time and within budget. Before that, she was a Project Director at the Asthma Research Center at Brigham and Women’s Hospital.
Lyn holds a Bachelor of Science in Nursing from the University of New Hampshire.