Clinical Study Manager (Medical Devices)

Location: Remote, United States; company headquartered in Plano, Texas. Travel to clinical sites and industry meetings may be required, up to 40%.

Company

hirify.global manufactures specialty medical products for interventional radiology, vascular surgery, interventional cardiology, and oncology.

What you will do

• Plan, design, execute, and oversee pre-market and post-market clinical investigations, including IDE studies, PMCF studies, registries, and observational studies.
• Lead assigned studies operationally from site selection through closeout, including timelines, milestones, risk mitigation, reporting, and study documentation.
• Coordinate site feasibility, qualification, initiation, monitoring, enrollment, performance, data quality, and closeout activities.
• Manage CROs, laboratories, and other vendors, including contracted deliverables, budgets, forecasts, resources, and expenditures.
• Monitor data quality and completeness, resolve data queries, and track study deliverables using clinical trial management tools.
• Provide guidance and training to CRAs and study team members while collaborating with Regulatory Affairs, Quality, Medical Affairs, and Product Development.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• At least 3 years of clinical research experience, including at least 2 years managing medical device studies.
• Direct experience working for a medical device company and managing pre-market and/or post-market clinical studies.
• Hands-on experience with site startup, enrollment management, monitoring oversight, and CRO management.
• Strong knowledge of ISO 14155, FDA regulations, EU MDR, GCP, medical device quality systems, and clinical documentation requirements.
• Proficiency with EDC, CTMS, and eTMF systems, along with strong project management, communication, leadership, and risk-management skills.

Nice to have

• Master’s degree or PhD.
• ACRP or SOCRA certification.
• Experience with interventional or procedural studies, particularly in interventional radiology, vascular surgery, or cardiology.

Culture & Benefits

• Remote work arrangement with travel to clinical sites and industry meetings as required.
• Cross-functional collaboration across clinical research, regulatory, quality, medical affairs, and product development.
• Opportunity to contribute to clinical evidence supporting product safety, performance, and regulatory objectives.
• This position is not eligible for visa sponsorship.