Senior Clinical Study Manager, MedTech Trials

North American Science Associates, Inc.; Northwood (OH); On-site; USD 84,000 - 163,000; Full time

Job summary

NAMSA is seeking a Clinical Study Manager to drive end-to-end clinical trial activities, from site initiation to close-out, coordinating cross-functional teams and ensuring data quality and regulatory compliance.

Responsibilities include developing study materials, tracking metrics, and supporting audits and inspections, with 20-30% travel. Bachelor’s degree and 3+ years’ experience required; English proficiency mandatory.

Qualifications

• Bachelor’s degree or equivalent in a related field.
• Minimum 3 years of clinical trial and/or monitoring experience.
• Project management experience.
• Fluency in English.
• Knowledge of Good Clinical Practices (GCP).
• Familiarity with regulations for medical device trials at various stages.
• Experience with regulatory submissions and site management.

Responsibilities

• Develops and maintains study materials, templates, SOPs.
• Manages site initiation, IRB/IEC submissions, and start-up.
• Tracks project metrics and prepares status reports for clients and teams.
• Coordinates site training, monitoring, and data quality.
• Supports audits and regulatory inspections and vendor audits.
• Ensures TMF quality and audit readiness; contributes to regulatory submissions.

Skills

Project management

Clinical trial experience

Communication

GCP knowledge

English fluency

Cross-functional collaboration

Data interpretation

Presentation skills

Education

Bachelor's degree or equivalent

Tools

EDC

CTMS

TMF

Job description

NAMSA is seeking a Clinical Study Manager to drive end-to-end clinical trial activities, from site initiation to close-out, coordinating cross-functional teams and ensuring data quality and regulatory compliance.

Responsibilities include developing study materials, tracking metrics, and supporting audits and inspections, with 20-30% travel. Bachelor’s degree and 3+ years’ experience required; English proficiency mandatory.