Status: Full Time, Exept

Travel: >50%

Reports To: Director of Clinical Operations

Number of Positions:  2

Locations: REmote - West Region and Central-Mid-West Region

Position Sumary

This role focuses on driving clinical study execution and operational excellence across GT Medical Technologies. Specifically achieved by identifying and effectively collaborating with existing and potential GT Medical Technologies clinical study sites and physicians that will be able to initiate new and/or expand upon existing GammaTile study programs within their respective institutions. This will be accomplished via rapid, focused GammaTile study program startup activities and successful enrollment in sponsor supported Clinical Studies, with specific focus on the current BRIDGES trial.

Positioned between traditional clinical study site management and commercial business development, this role focuses on external relationship building and leadership, data-driven site analysis, and cross-functional execution to maximize clinical adoption, clinical study patient enrollment and use of GammaTile which will in turn lead to broader overall adoption and utilization. This role will lead and/or coordinate efforts between/across Clinical Operations, Medical Affairs, and Commercial/Marketing business functions to ensure optimal study placement, strong KOL relationships, and predictable study enrollment.

This role will establish and maintain critical relationships with key study site decision makers such as Neurosurgeons, Radiation Oncologists, Physicists, and Medical/Neuro Oncologists and/or administrative staff, depending on the institution. To build these relationships a strong grasp of and ability to effectively communicate product details and clinical study protocols are required. Strong internal cross-functional relationships, across all levels within GT Medical Technologies are also vital for successful execution of all studies.

Job Duties/Responsibilities

Strategic Clinical Study Site Identification and Enrollment

• Apply clinical knowledge and expertise to optimize recruitment strategies, enrollment forecasting, and study placement decisions of potential study sites
• Identify, evaluate, and prioritize potentially high-performing clinical study sites aligned with establishing and/or expanding a site’s GammaTile program 
• Establish study site profiles including existing & potential patient population, competing studies, clinical research operational infrastructure, clinical cross-discipline and primary investigator interest
• Maintain open communication and relationships with key site personnel including Principal Investigator, Research Coordinator, as well as regulatory personnel
• Adhere to specific site nomination, qualification and startup processes
• Leads initial and ongoing training/retraining of all site stakeholders as necessary to ensure protocol adherence

Account Growth Potential & Strategy

• Develop patient throughput models to assess study site clinical research efficiency and identify utilization growth drivers and opportunities
• Develop and help execute Company strategies for Clinical and Commercial growth through both new institution identification & onboarding as well expanded use by active institutions through clinical study participation
• Contribute to account performance by providing clinical insights and intelligence as a clinical study subject matter expert
• May attend key sales meetings as needed (such as Quarterly Business Reviews) to support Territory Managers and/or Area Directors and help open and/or expand accounts through clinical excellence 

Clinical Study Startup Excellence and Acceleration

• Serve as an internal strategic liaison across Clinical Operations, Medical Affairs, Marketing, and Commercial teams to identify and accelerate new clinical study site opportunities while also partnering with existing clinical study partners to expand existing use of GammaTile  
• Partnering with Clinical Operations colleagues to streamline feasibility, prioritize site selection, and track & communicate projected activation timelines
• Engage in meaningful clinical dialogue as a scientifically credible external-facing partner to sites and institutions
• Lead and support entire study site activation process and lead SIV preparation and execution
• Apply industry standard best practices to optimize GT Medical’s clinical study execution
• Train facility staff regarding protocol requirements and technology
• Embodies the Company’s purpose and shared values, building a positive and productive team culture.
• Comply with Company policies and procedures.
• Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
• Other duties as assigned.

• Bachelor’s degree in Healthcare, Biologic or Chemical Sciences, Medical Business, or a related field.
• 5+ years of experience in Life Sciences industry with specific knowledge of clinical study operations
• Strong clinical knowledge foundation with the ability to engage in meaningful clinical dialogue with clinical study site representatives and clinicians
• Excellent oral and written communication skills and audience awareness 
• Strong and diverse stakeholder management skills
• Ability to think strategically while executing operationally
• Possess independent problem-solving skills and ability to make decisions
• Proficient in using Microsoft office programs (Outlook, Word, Excel, and PowerPoint).
• Willingness to work a flexible schedule. 
• Able to travel for work regularly.
• Satisfactorily pass comprehensive background screening. 
• Satisfactorily pass drug screening (if applicable to position).

Physical Demands/Working Conditions

• Typical work environment for a professional or home office space.
• May work in a variety of environments (hotel, events, hospital, etc.)
• Somewhat of a stationary role with frequent moving from place to place.
• Constant use of a computer, keyboard, mouse, monitor and other office equipment.
• Occasionally picks up, carries, and moves items up to 50 lbs.
• Some evening and weekend work depending upon workload.
• Frequent overnight travel will be required for work, events, and trainings.