NAMSA · 2 hours ago
Senior Study Director
Minneapolis, MN
Full-time
Onsite
Mid, Senior Level
$81K/yr - $120K/yr
4+ years expNAMSA is a pioneering organization in the medical device industry, focusing on materials safety since 1976. They are seeking a Senior Study Director to coordinate study conduct tasks, manage client communications, and ensure compliance with regulatory standards throughout the study lifecycle.
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
Develops and leads complex study design and protocols
Participates in client discussions regarding study design and product development goals including regulatory submission pathway
May prepare publications and/or presentations and participate in conferences, webinars, or other industry venues
Provides mentoring and training to other Study Directors
Other duties as assigned
Qualification
Required
Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with a minimum of four years' related GLP laboratory experience
Master's degree/PhD with a minimum of three years' of related GLP laboratory experience
Three years previous study directing experience preferred
Preferred
Three years previous study directing experience preferred
Company
NAMSA
NAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2020-09-01Acquired
Leadership Team
Matthew Micowski
SVP & CFO
Timothy Mitchell
VP - Strategic Partnerships & MRO
Recent News
Medical Device Network
2026-01-11
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