Clinical Study Manager (Late 2025)

Clinical Study Manager

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.

Mission

to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core values.

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 :

Clinical Study Managers (CSM) are responsible for the timely execution and high quality implementation of some or all the following clinical study activities based on project-specific work orders, study complexity and CSM role-level (e.g., Associate vs. Senior, etc.) :

Qualifications & Technical Competencies :

Bachelor's degree or equivalent experience in a related field, with a minimum 3 years of relevant clinical trial and / or monitoring experience; and Project management experience.

Fluency in English and local language, if different, required.

Knowledge of Good Clinical Practices.

Knowledge of regulations that apply to medical device trials at various stages of development (feasibility, pivotal, post-market) and ability to adapt trial oversight accordingly.

Familiarity with the clinical trial process

Understanding of site escalation process for compliance issues.

Multidiscipline (at least 2 therapeutic areas) therapeutic knowledge.

Familiarity with medical device development process from pre-clinical to commercialization.

Understanding of 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 / REB personnel (and to persuade them to do what is needed).

Ability to prepare slides and present complex information professionally and clearly; strong speaking skills.

Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.

Working Conditions :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and / or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.

Extensive use of a computer keyboard.

Travels as needed (typically between 20-30%) to meet project milestones.