Prior to joining the MMRF, Clinical Operations Manager Karen Woolley had over 15 years of experience in clinical research starting out as a research coordinator/data manager at Memorial Sloan Kettering Cancer Center and then moving into the role of a Clinical Study manager working on clinical trial Phases I-IV, at Roche, Pfizer, Eisai and Forrest Labs she has extensive experience in:
Drug Development
NDA Submissions
Audit Preparation
Audit Resolution
Project Management
Negotiation
Vendor Management
Relationship Management
Process Improvement
At the MMRF Karen as a Clinical Operations manager she is responsible for the overall day to day project management communications/support among the MMRF and MMRC clinical trials (Phase I-II), network sites and industry/CRO partners. She works with the CRO’s to ensure appropriate Project Plans are established and implemented and managed. Karen negotiates study budgets and assists with the execution of site contracts. Oversees the coordination and communications associated with trial meeting planning and drives trial execution according to MMRCC start up and enrollment benchmarks.
It’s exciting to work with the investigators and the Multiple Myeloma Project Managers at the consortium sites assisting in the opening of trials for new therapy which could be a potential cure or can extend someone’s life. Multiple Myeloma does not discriminate it effects everyone. I am very proud to be a part of an organization that is truly making a difference. Working with the multiple myeloma consortium sites and industry partners to get the results from the studies analyzed to finding the next piece to solve the puzzle.