Note: The job is a remote job and is open to candidates in USA. GT Medical Technologies, Inc. is seeking a Clinical Study Site Lead to drive clinical study execution and operational excellence across its clinical study sites. The role identifies and develops high-performing sites, supports study startup and enrollment, builds relationships with clinical stakeholders, and coordinates cross-functional efforts to expand GammaTile study programs.
Responsibilities
- 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
- 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
- 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
Skills
- 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)
Benefits
- Full-time employment
- Remote work in the West Region and Central-Mid-West Region
- Flexible schedule
- Company-provided training and retraining for site stakeholders
- Frequent overnight travel for work, events, and trainings
Company Overview