Study Director – GLP/Preclinical Research & Client Lead

namsa; Northwood (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

NAMSA is seeking a scientifically trained professional to coordinate GLP and non-GLP preclinical studies, serving as primary client contact and ensuring regulatory compliance. The role involves study design, data interpretation, and cross-functional collaboration to meet project timelines.

The ideal candidate will have a Bachelor’s in a science field with lab experience, and a Master’s or PhD with related experience. Strong communication and teamwork are essential in this hands-on environment.

Qualifications

• Requires a Bachelor's degree in a scientific field with at least two years of related lab experience.
• Master's degree or PhD with at least one year of relevant laboratory experience.

Responsibilities

• Coordinate study conduct from initiation to completion.
• Serve as primary client contact and keep the client informed of schedule and issues.
• Ensure compliance with ISO, GMP, GLP and NAMSA SOPs.
• Act as Study Director for GLP and non-GLP preclinical studies.
• Prepare protocol submissions for IACUC review and respond to comments.
• Interact with clients, auditors, inspectors, subcontractors and other stakeholders.
• Develop and lead moderately complex study designs and communicate schedule to clients.
• Manage schedule, budget and quality commitments for the client.
• Mentor internal multidisciplinary teams to meet client expectations.
• Understand investigational products and the Medical Device Development Process.
• Assist with departmental training.

Skills

Study coordination

GLP

Compliance

Client communication

Education

Bachelor's degree in science

Master's degree/PhD with related lab experience

Job description

NAMSA is seeking a scientifically trained professional to coordinate GLP and non-GLP preclinical studies, serving as primary client contact and ensuring regulatory compliance. The role involves study design, data interpretation, and cross-functional collaboration to meet project timelines.

The ideal candidate will have a Bachelor’s in a science field with lab experience, and a Master’s or PhD with related experience. Strong communication and teamwork are essential in this hands-on environment.