Senior Project Manager
Senior Project Manager
Missy Lavinder has over 18 years of clinical trial experience, providing clinical operations oversight and project management within the clinical trial arena.
Beginning her career with a focus in Neurosciences research, she has spent the past 6 years conducting pain, dermatology, genetic, and rare disease trials. On both U.S. and global programs, Ms. Lavinder has provided oversight and full management support for multiple pain and dermatology studies and multiple rare disease studies.
Recently, Ms. Lavinder served as the Project Manager for a highly complex trial in Hereditary Angioedema, a rare genetic condition, which ultimately led to FDA approval of the treatment. Ms. Lavinder has also provided oversight and management of clinical trial programs in Otitis Media, Dermatology, and rare inherited peripheral neuropathy and neurodegenerative conditions, where her duties included the management of non-interventional/observational studies and Phase 1 – 4 clinical trials. She has also directed several studies requiring the oversight of data safety monitoring boards and data monitoring committees.
Ms. Lavinder is a seasoned team leader with particular expertise in risk-based quality management and risk-based monitoring within Rho’s robust E6R2 framework. She has a strong understanding of all aspects of product development, which has allowed her to successfully lead teams to meet or exceed timelines, while always maintaining trial integrity.
Ms. Lavinder earned a bachelor’s degree in Psychology from Appalachian State University in Boone, NC.
Why clinical research?
“Like many other new graduates with a degree in Psychology, I was uncertain of my ultimate career path. I was fortunate to be offered a Study Coordinator position at the Neurosciences Hospital at UNC-Chapel Hill. While I’ll be the first to admit, I was not certain what this role entailed at first, but I quickly learned the meaning of clinical trials and the importance of my role as a Study Coordinator thanks to a very experienced Clinical Research Associate that visited our clinic site often. She took me as her protégé and laid the foundation of my knowledge and passion for clinical research. During my tenure at UNC, I was fortunate to observe and learn from the site’s perspective as well as engage in patient-facing clinical work. Eventually, this experience drove me to explore other avenues within the clinical research space and led to my past roles as an in-house CRA, Regulatory Associate/Site Start-up Specialist, Clinical Operations Manager, and Project Manager. All of these experiences have built upon one another and ultimately, allowed me to see the big picture.”
This is what drives Missy:
“Quite simply, helping those in need. Over the past few years, I have been fortunate enough to manage a large multi-center trial for the prevention against acute attacks of Hereditary Angioedema. Ultimately, the FDA approved the treatment and it was truly fantastic to be a part of such a successful program. So, after many years of complex trial management, knowing that this very sick patient population now has the option for an approved treatment … makes all the trials and tribulations completely worth it.”
Content by Missy Lavinder
Successful implementation of RBQM is a challenge many in our industry are facing. To understand what it is and how it impacts the management of your clinical trial, this webinar will address what exactly E6R2 is. We will use Rho as a case study for designing and implementing a strategy, discuss common misconceptions, and review lessons Rho has learned through implementation of RBQM.