Clinical Project Manager

The Clinical Project Manager is responsible for sponsor-side planning, coordination, and execution of Nova Scan’s clinical research programs supporting the development and regulatory approval of its surgical medical device technologies. The initial focus will be clinical trials of Margin Scan™, Nova Scan’s electrical impedance-based surgical margin assessment platform. This position will own day-to-day clinical operations from protocol finalization and site selection through study initiation, enrollment, monitoring, database closeout, and site closure.

The Clinical Project Manager will work closely with Nova Scan leadership, clinical investigators, regulatory and statistical consultants, clinical research organizations (CROs), site monitors, and other vendors to ensure studies are completed on schedule, within budget, and in compliance with applicable FDA regulations and Good Clinical Practice (GCP).

• Coordinate development, review, and operational finalization of clinical protocols, informed consent documents, case report forms, study manuals, monitoring plans, and other study documentation.
• Develop and implement clinical operations SOPs and study-specific procedures consistent with FDA requirements, GCP, Nova Scan’s Quality Management System, and applicable regulatory requirements.
• Develop study timelines, enrollment plans, budgets, milestones, risk assessments, and operational metrics; identify issues and implement corrective actions.
• Identify clinical investigators and study sites based on patient volume, research capabilities, and study-specific requirements; manage contracting, clinical trial agreements, study budgets and site activation in coordination with leadership.
• Coordinate IRB submissions, collection of required regulatory documents, site training, and Site Initiation Visits.
• Monitor site enrollment, protocol compliance, data quality, study documentation, investigational-device accountability, and overall site performance.
• Identify, select, and manage CROs, central IRBs, data-management providers, statistical resources, and other clinical vendors.
• Establish and maintain complete and inspection-ready Trial Master Files and ensure appropriate collection, reconciliation, version control, and retention of essential study documentation.
• Support FDA submissions, regulatory inspections, scientific publications, and subsequent clinical-development and reimbursement activities using study-generated evidence.

DEPARTMENT: Clinical Operations

REPORTS TO: Chief Operating Officer

LOCATION: Houston, TX

EMPLOYMENT STATUS: Full-Time

• Bachelor’s degree in life sciences, nursing, biomedical sciences, clinical research, public health, or a related discipline required.
• Minimum 5 years of clinical research/clinical operations experience, preferably including sponsor-side responsibility for clinical study execution.
• Experience with FDA-regulated medical device clinical trials strongly preferred.
• Strong working knowledge of ICH GCP, FDA clinical investigation requirements, IRB processes, and clinical research documentation.
• Experience with site feasibility, qualification, contracting, and study budgeting.
• Experience supporting De Novo, 510(k), IDE, or other FDA medical-device submissions is preferred.
• Experience in an early-stage medical device or biotechnology company is highly desirable.
• CCRA, CCRP, PMP, RAC, or comparable professional certification is desirable but not required.

• Expertise in clinical research operations and strong knowledge of GCP.
• Excellent project-management skills with the ability to manage timelines, budgets, sites, vendors, and multiple competing priorities.
• Ability to identify operational risks, solve problems proactively, and…