Clinical Study Manager - MedTech Trials PM Lead

NAMSA; United States; Remote; USD 84,000 - 163,000; Full time

Job summary

The role requires 3+ years of clinical trial experience, project management skills, and strong GCP knowledge. Travel typically 20–30%; NAMSA offers a competitive compensation package and equal opportunity employment.

Qualifications

• Bachelor’s degree or equivalent experience in a related field (minimum).
• 3+ years of relevant clinical trial and/or monitoring experience.
• Fluency in English and local language, if different, required.

Responsibilities

• Develops and maintains foundational study materials, templates, SOPs and review processes.
• Creates and manages study tracking tools and reports.
• Supports internal clinical team members with protocol training, site management and issue resolution.
• Drives site activities from start-up through close-out, including site selection, regulatory submissions and budget negotiations.
• Ensures regulatory document collection and review and maintains investigator site files.
• Collaborates with Project Management to monitor metrics, track deliverables and communicate status to clients.
• Drives cross-functional deliverables and ensures TMF quality and audit readiness.
• Travels 20–30% to meet project milestones.
• Leads multidisciplinary clinical projects and manages cross-functional teams.

Skills

English fluency

Project management

Good Clinical Practices

Clinical trial monitoring

Education

Bachelor’s degree or equivalent experience in a related field

Tools

EDC

CTMS

TMF

Job description

The role requires 3+ years of clinical trial experience, project management skills, and strong GCP knowledge. Travel typically 20–30%; NAMSA offers a competitive compensation package and equal opportunity employment.