Description
The Clinical Trial Manager is responsible for managing the operational implementation of studies to support the development and commercialization of novel assays which lead to improved treatment decisions for oncology patients; and investigator and other collaborative studies to support the use of the commercial assays in facilitating treatment decisions for patients. The CTM I is expected to provide functional expertise to study teams. This position reports to the Senior Director, Medical Operations and Data Management.- Develop working knowledge of study initiation, execution, analysis and closing procedures; study-related documentation; program and business goals and milestones
- Monitor study progress from study initiation through publication of study results, including but not limited to maintenance of the study timeline; execution of tasks by functional area; regulatory and protocol compliance
- With study team members, identify potential problems and issues; prioritize relative to program and business goals; escalate to program leadership if appropriate
- Facilitate the development and timely completion of study-related documents
- Deliver accurate and timely study-related progress reports to program leadership and senior management
- Coordinate and maintain effective collaborator communications for specimen tracking, study conduct and/or data review
- Creates study-specific files; collects and maintains all required documentation and correspondence
- Bachelor's degree, Life Sciences preferred
- At least 4 years related experience in the health care, biotechnology or diagnostics industry
- Excellent knowledge of Microsoft tools including Word, Excel, PowerPoint, and Project
- Excellent oral and written communication skills
- Demonstrated ability to deliver quality results in a timely manner
- Well-organized and detail oriented
- Enjoys working in rapid, fast paced work environment
To find out more about Real please visit www.realstaffing.com