Develop working knowledge of GHI study initiation, execution, analysis and closing procedures; study-related documentation; and study, program and business goals and milestones;
Evaluate, recommend and present to program and/or business senior leadership 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;
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;
Present escalated 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 budget and forecasts to Finance and Business Development leaders;
With direct manager, 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
8+ years of 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; Clinical Trial Management Systems (CTMS) and Project Portfolio Management (PPM) software;
Demonstrated excellent oral, written and presentation communication skills;
Demonstrated ability to independently and direct others to 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 and influential in a fast-paced, rapid growth environment.
Willing and able to travel, as required.
Demonstrated proficiency in the utilization of Planview.
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