The Clinical Trial Manager (CTM) I at Genomic Health, Inc. ("GHI") 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 in Medical Operations reports to the Senior Director, Medical Operations and Data Management.
- Develop working knowledge of GHI study initiation, execution, analysis and closing procedures; study-related documentation; and study, 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.
- Learn and utilize project management tools and best practice processes and procedures, to support efficient and effective study execution.
- Participate in and represent function at study team meetings.
- 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, including but not limited to protocols; and data management and analysis plans.
- 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, to include but not limited to periodic teleconferences and face-to-face meetings.
- Creates study-specific files; collects and maintains all required documentation and correspondence.
- Bachelor's degree in life sciences, scientific or other relevant discipline.
- 0 - 2 years related experience in the health care, biotechnology or diagnostics industry.
- Familiarity with Microsoft tools, specifically Word; Excel; PowerPoint; and Project.
- Demonstrated excellent oral and written communication skills.
- Demonstrated ability to deliver quality results in a timely manner.
- Well-organized and detail oriented.
- Comfortable to be in a fast-paced, rapid growth environment.
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