The Senior 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 Senior CTM I is expected to provide functional expertise to, and project planning and management for study and clinical 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
- Utilize project management tools and best practice processes and procedures, to support efficient and effective study execution
- Participate in and represent function at study and clinical team meetings
- Coordinate and lead study and clinical team meetings, including but not limited to: prepare agenda; document decisions and action items; issue minutes
- With study team members, identify potential problems and issues; prioritize relative to program and business goals; escalate to program leadership if appropriate
- Present escalated study team problems and issues to clinical team leaders
- 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
- Ensure that files for study-related documents are accurate, current and complete
- Ensure the accurate and timely payment and tracking of invoices to investigators
- Participate in recruiting and hiring of staff
- Train and mentor new and/or lower-level staff.
- Bachelor's degree in life sciences, scientific or other relevant discipline
- 5 - 8 years related experience in the health care, biotechnology or diagnostics industry
- Demonstrated competency in the utilization of Microsoft tools, specifically Word; Excel; PowerPoint; and/or Project
- Demonstrated excellent oral, written and presentation communication skills
- Demonstrated ability to independently deliver quality results in a timely manner
- Demonstrated excellent organization skills and detail orientation
- Demonstrated competency with project management processes and procedures
- Demonstrated ability to be highly effective in a fast-paced, rapid growth environment.
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