Clinical Study Lead – MedTech Trials

North American Science Associates, Inc.; United States; Remote; USD 84,000 - 163,000; Full time

Job summary

NAMSA is seeking an experienced Clinical Trial/Project Manager to lead FDA-regulated medical device studies from site start-up to close-out. The role coordinates protocol development, training, site management and regulatory submissions, ensuring data quality and audit readiness across multiple projects.

Required is a bachelor’s degree in a related field with 3+ years of clinical trial experience, along with GCP knowledge and strong cross-functional communication skills.

Qualifications

• Bachelor’s degree in a related field with at least 3 years of clinical trial/monitoring experience.
• Project management experience.
• Fluency in English and local language, if different, required.
• Knowledge of Good Clinical Practices (GCP) and medical device trial regulations.

Responsibilities

• Develops and maintains foundational study materials and tools (protocols, training slides, ICFs, templates, SOPs, etc.).
• Creates and manages study tracking tools and reports.
• Supports internal clinical team with protocol training, site management and issue resolution.
• Drives site activities from start-up through close-out, including site qualification, regulatory submissions, budgeting, initiation, and monitoring.
• Ensures study master file quality and audit readiness; prepares regulatory deliverables for submissions.

Skills

Project management

Fluency in English

GCP knowledge

Regulatory knowledge

Education

Bachelor’s degree in a related field

Job description

NAMSA is seeking an experienced Clinical Trial/Project Manager to lead FDA-regulated medical device studies from site start-up to close-out. The role coordinates protocol development, training, site management and regulatory submissions, ensuring data quality and audit readiness across multiple projects.

Required is a bachelor’s degree in a related field with 3+ years of clinical trial experience, along with GCP knowledge and strong cross-functional communication skills.