Clinical Study Manager - MedTech Trials & Project Lead

North American Science Associates, Inc.; Northern (KY); Hybrid; USD 69,000 - 134,000; Full time

Job summary

NAMSA seeks an experienced clinical trial professional to lead site management and regulatory activities across projects. You will drive start-up to close-out tasks, coordinate with sponsors, and ensure data integrity and compliance with GCP and device regulations.

Travel is expected 20-30% to meet milestones, and you will collaborate with cross-functional teams to deliver study deliverables and maintain TMF readiness.

Qualifications

• Bachelor’s degree or equivalent in a related field, with a minimum 3 years of relevant clinical trial and/or monitoring experience.
• Project management experience.
• Fluency in English and local language, if different, required.
• Knowledge of Good Clinical Practices (GCP).
• Knowledge of regulations that apply to medical device trials at various stages of development and ability to adapt trial oversight accordingly.
• Familiarity with the clinical trial process and site escalation for compliance issues.
• Understanding of data management and biostatistics in the clinical trial process.

Responsibilities

• Develops and maintains foundational study materials and tools, coordinating review processes.
• Creates and manages study tracking tools and reports.
• Supports internal clinical team members and site management activities.
• Drives project-level deliverables, including milestones, reporting, and client communications.
• Leads site activities from start-up through close-out, including site selection, regulatory submissions, budgeting, training, screening, enrollment and monitoring.
• Ensures adherence to SOPs, GCP, and regulatory guidelines; conducts site audits and sponsor meetings.

Skills

Project management

English fluency

Clinical trial knowledge

Regulatory knowledge

Education

Bachelor’s degree in related field

Job description

NAMSA seeks an experienced clinical trial professional to lead site management and regulatory activities across projects. You will drive start-up to close-out tasks, coordinate with sponsors, and ensure data integrity and compliance with GCP and device regulations.

Travel is expected 20-30% to meet milestones, and you will collaborate with cross-functional teams to deliver study deliverables and maintain TMF readiness.