MassBio Ed is hosting a series of new courses in 2012, including a six-week course beginning April 26, 2012 on Managing Clinical Trials offered in collaboration with Halloran.
It is intensely demanding to manage and ensure oversight of outsourced clinical trials, especially in the current development environment of regulatory scrutiny of the sponsor/ CRO relationship, cost consciousness, global programs, the use of numerous vendors and the need to become more efficient and process oriented. Often a clinical project team spends little time together face-to-face, but must form and seamlessly execute intricate protocols in unrealistic time to exacting standards. The individual who is charged with making the study a success is a clinical study (project) manager, who should lead the effort from the sponsor's perspective, but who must partner with counterparts at vendor companies to maximize productivity and positive outcomes. Although the team is also accountable, the priorities and constraints are considerably different, challenging the study manager uniquely to influence performance, often at a distance and usually to individuals who are not direct reports.
This modular workshop will introduce the major skills needed to manage outsourced clinical studies within a CRO/sponsor environment.
Location:
Massachusetts Biotechnology Council, One Cambridge Center in Cambridge, Massachusetts.
Fees:
$1500 for MassBio Members; $1650 for non-members.
Included will be vendor selection and qualification, project planning and kickoff, risk planning, assigning responsibilities, and leading and overseeing a diverse team. Using case studies and interactive exercises combined with lecture and discussion, participants will plan an outsourced project, select and qualify vendors and set expectations for adequate documentation of oversight and communication to manage a clinical study. Participants will take away useful tools and techniques to apply immediately, and to assist them with building their skills in managing outsourced clinical projects in a highly scrutinized regulatory environment.