Senior Study Director

North American Science Associates•Minneapolis, MN

2d•$81,100 - $120,000

About The Position

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. 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.

Requirements

Three years previous study directing experience preferred.
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.

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.