Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. Learn more: https://namsa.com/about/client-testimonials
Manager, Clinical Operations
Location
United States
Posted
50 days ago
Salary
Not specified
Job Description
Job Requirements
- Bachelor’s degree or equivalent experience in a related field, with a minimum of 5 years of relevant experience.
- Fluency in English and local language, if different, required.
- Knowledge of Good Clinical Practices and other regulations which apply to clinical trials at various stages of development (feasibility, pivotal, post-market)
- Familiarity with Medical Device product development process.
- Familiarity with the role of study management, data management and biostatistics in the clinical trial process.
- Familiarity with the type and quality of data needed from a clinical trial and how it should be presented
- Learn and familiarize 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, central lab management, and site compliance escalation.
- Familiarity with the global regulatory landscape for clinical research
- Ability to effectively communicate with and positively influence clients
- Ability to participate in and present during regulatory inspections of NAMSA
- 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.
- Expertise in Microsoft Office suite of products (e.g. Excel, Word, PowerPoint, etc.)
- Ability to travel up to 20%; some international travel may be required
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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