Associate Study Director/Study Director

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 pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description:

• Assists in the coordination of study conduct tasks from study initiation to study completion.
• Performs noncomplex studies and serves as the primary contact for the client, as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
• Performs project in compliance with applicable quality system regulations (i.e. ISO, GMP, GLP) and NAMSA SOPs.
• Knows and understands the Animal Welfare Requirements and serves as Principal Investigator, when applicable.
• Serves as the Study Director for GLP and non-GLP preclinical studies and assures that all applicable GLP regulations are followed.
• May need to participate in study specific procedures.
• Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report.
• Assures that all data including unanticipated responses are accurately recorded, verified and organized.
• May need to ensure that study records for GLP studies are archived upon completion of the study.
• May need to interact with regulatory bodies (i.e. FDA, NMPA, ANSM, etc)
• Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary.
• Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Participates in client discussions regarding study design when needed.
• Develops and leads moderately complex study designs as needed, serves as the primary contact for the client as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
• Establishes and ensures schedule, budget and quality commitments are met for the client.
• Manages (motivates, communicates) internal multidisciplinary team members to ensure that client expectations are met.
• Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
• Evaluates, analyzes, and interprets study data and presents in a clear, well-organized, scientifically sound report.
• Assists with departmental training as needed.
• Other duties as assigned.

Qualifications & Technical Competencies:

• Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with a minimum of two years' related laboratory experience.
• Master's degree/PhD with a minimum of one year of relevant laboratory experience.

Working Conditions:

• While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens.
• The noise level in the work environment is usually moderate.
• While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination.

NAMSA is an equal employment opportunity company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.