Study Director

NAMSA•Northwood, OH

19h•Onsite

About The Position

NAMSA pioneered the industry as the first independent company in the world to focus solely on medical device materials for safety, contributing significantly to the development of industry test methods. As the industry's premier provider, NAMSA supports clients through every step of the product development lifecycle. The company's vision is to inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success. Its mission is to deliver best-in-class global MedTech development solutions through its people, expertise, and technology, adhering to core values of integrity, best-in-class customer experiences, superior talent development, agility, timely results, collaboration, and diverse perspectives. The Study Director assists in coordinating study conduct tasks from initiation to completion, performs noncomplex studies, and serves as the primary client contact, keeping them informed of schedules and unforeseen events. This role ensures project compliance with applicable quality system regulations (ISO, GMP, GLP) and NAMSA SOPs, understands Animal Welfare Requirements, and may serve as Principal Investigator. The Study Director is responsible for GLP and non-GLP preclinical studies, ensuring all applicable GLP regulations are followed, and may participate in study-specific procedures. Key responsibilities include evaluating, analyzing, and interpreting data to present in clear, scientifically sound reports, and ensuring all data, including unanticipated responses, are accurately recorded and verified. The role may also involve archiving study records for GLP studies, interacting with regulatory bodies, preparing protocol submissions for IACUC review, and engaging with clients, auditors, and other stakeholders. The Study Director participates in client discussions regarding study design, develops and leads moderately complex study designs, establishes and ensures schedule, budget, and quality commitments are met, and manages internal multidisciplinary team members. A high-level understanding of investigational products and the Medical Device Development Process is required. Additionally, the Study Director assists with departmental training.

Requirements

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.

Responsibilities

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.
Understand 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.