Manager, Clinical Study Management

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 theMission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our coreValues: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:• Bachelor’s degree or equivalent experience in a related field, with a minimum of 5 years of relevant experience including 2 years of management experience. Advanced degree preferred. • Knowledge of Good Clinical Practices and other regulations which apply to medical device trials at various stages of development (feasibility, pivotal, post-market) and ability to adapt trial oversight accordingly.• Familiarity with all aspects of the clinical trial process including, but not limited to protocol development, site selection/qualification, site initiation, monitoring, close-out, investigator meetings, DSMB/CEC, core lab management, and site compliance escalation.• Multidiscipline (at least 2 specialties) therapeutic knowledge.• Familiarity with medical device development process from pre-clinical to commercialization.• Understanding of the role of data management and biostatistics in the clinical trial process.• Understanding of the type and quality of data needed from a clinical trial and how it should be presented.• Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC personnel, and clients (and persuade them to do what is needed).• Ability to participate in and present during an FDA/notified body/regulatory inspection• Strong management and strategic business mindset and skills.• Ability to provide work direction, to include organizing, prioritizing, negotiating, communicating relevant project information and scheduling work assignments.• Ability to handle multiple priorities and issues, foster a cooperative work environment with high quality standards, and facilitate and manage effective meetings.

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