Description
Responsibilities:- 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 is expected to provide functional expertise to, and project planning and management for study and clinical teams.
- The Senior CTM may have functional supervisory responsibilities for new and/or lower level staff.
- 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;
- 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.
Qualifications:
- Bachelor's degree in life sciences, scientific or other relevant discipline.
- 6-9 years related experience in the health care, biotechnology or diagnostics industry.
- Demonstrated competency in the utilization of Microsoft tools, specifically Word; Excel; PowerPoint;
- Demonstrated excellent oral, written and presentation communication skills.
- Demonstrated ability to independently and direct others to deliver quality results in a timely manner.
- Demonstrated competency with project management processes and procedures.
To find out more about Real please visit www.realstaffing.com