The Principal Clinical Trial Manager 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. He/she is expected to provide functional expertise to, and project planning and management for study and clinical teams. The Principal Clinical Trial Manager may have functional supervisory responsibilities for new and/or lower level staff. This position in Medical Operations reports to the Senior Director, Translational Sciences.
Develop working knowledge of GHI study initiation, execution, analysis and closing procedures; study-related documentation; and study, program and business goals and milestones;
Drive the evaluation, recommendation and delivery of best practice, process improvement, and other ideas and initiatives to improve efficiency and effectiveness;
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;
Drive, recommend and ensure the utilization of 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;
Identify and escalate within and across-study team problems and issues to clinical and program team leaders;
Ensure the development and timely completion of study-related documents, including but not limited to protocols; and data management and analysis plans;
Ensure the accurate and timely delivery of 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;
Prepare and manage budget and forecasts to Finance and Business Development leaders;
Will directly manage, recruit and hire staff;
Mentor and supervise new and/or lower level staff.
Bachelor’s degree in life sciences, scientific or other relevant discipline
Post-graduate course work in a life sciences, scientific or other relevant discipline
12+ years related experience in the health care, biotechnology or diagnostics industry;
Demonstrated proficiency in the utilization of Microsoft tools, specifically Word; Excel; PowerPoint; and/or Project; Clinical Trial Management Systems (CTMS) and Project Portfolio Management (PPM) software;
Demonstrated excellent oral, written and presentation communication, influencing and negotiating skills;
Demonstrated ability to independently and direct others to deliver quality results in a timely manner;
Demonstrated excellent organization skills and detail orientation;
Demonstrated proficiency with project management processes and procedures;
Demonstrated ability to be highly effective and influential in a fast-paced, rapid growth environment.
Willing and able to travel, as required.
Demonstrated proficiency in the utilization of Planview