Senior Clinical Trials Manager
Genomic Health - Redwood City, CA

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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.

Responsibilities:

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.

Qualifications:

Education:

Bachelor’s degree in life sciences, scientific or other relevant discipline

Experience:

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.

Genomic Health - 21 months ago - save job - copy to clipboard
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About this company
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Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that address the overtreatment...