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NAMSA · 2 weeks ago

Study Director (NAMSA Talent Building Community)

Northwood, OH

Full-time

Onsite

Entry, Mid Level

2+ years exp

NAMSA is a pioneering company focused on medical device materials for safety, providing support throughout the product development lifecycle. The Study Director will coordinate study conduct tasks, serve as a primary contact for clients, and ensure compliance with quality regulations while managing study designs and data interpretation.

Medical Device

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

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

Qualification

GLP regulationsAnimal Welfare RequirementsMedical Device DevelopmentLaboratory experienceClient communicationData analysisProject managementTeam collaboration