Manager, Clinical Operations

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 planning, and coordinating both global and regional clinical, biostatistics and data management operational activities of the Clinical Department as applicable.
• Manages select Clinical Associates within the Clinical Department.
• Allocates workload for all clinical, biostatistics and data management projects; May take on all the duties and responsibilities of one or more of the functions of the direct reports and/or lead projects, as needed
• Confirms appropriate regulations and procedures are applied and followed for relevant operational services. Works with regional Director and global leaders to balance alignment with local requirements and global approach.
• Works with staff to ensure client expectations are met including schedule, cost and quality of services.
• Assists direct reports in developing effective strategies for communicating with and motivating project team members.
• Intervenes and problem-solves with challenging clients as necessary.
• Provides opportunities and coaching to promote education and further direct reports’ understanding of the clinical development process including client business strategy, local regulatory and marketing requirements, and challenging financial, technical, client service and timeline issues.
• In conjunction with the global team, proposes and implements systems to support internal improvement and NAMSA’s long-term growth.
• Maintains qualified staff by recruiting, selecting, orienting, and training Associates, and developing personal growth opportunities via training plans, quality oversight/assurance and/or career path planning.
• In support of the clinical department financial goals, may assist with budget forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
• Participates in meetings with prospective clients.
• May present on clinical topics at regional and local conferences, seminars and NAMSA events, as needed, and supports team member involvement in these activities.
• Provides scope of project and relevant information to support the creation of proposals. Identifies opportunities to bring in new projects/clients.
• Offers opportunities to clients for expansion of services to be provided by NAMSA.

Qualifications & Technical Competencies

• Bachelor’s degree or equivalent experience in a related field, with a minimum of 5 years of relevant experience. Global experience preferred
• 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

NAMSA was founded on the principals of delivering quality customer service, conducting ourselves with integrity, respect for one another, open communication and collaboration. Whether you have a background in Laboratory Science, Clinical Research, Regulatory Affairs, Quality Assurance, Engineering, or Sales & Business, NAMSA offers exciting opportunities to align with your expertise.