Clinical Study Manager - 100% Remote, US
Location: Saint Louis
Posted on: May 16, 2022
NAMSA pioneered the industry, NAMSA 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
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
Come and work for an organization whose:
Mission is to make a scientific contribution to every medical
device in the world.
Culture is passionately committed to the partnership between one
another and our clients to improve a nd save lives through a
respectful, trusting, and collaborative environment.
Values have stood the test of time.
Above all else, conduct ourselves with integrity
Clinical Study Manager Position Summary
As a Clinical Study Manager you are a member of the Clinical
Services group. This role requires a clinical trials expert to
manage all aspects of global clinical trials, including budgeting
for the entire study, oversight of full-service operations, along
with the technical and therapeutic aspect of the trials. You are a
creative problem-solver, with strong attention to detail, flexible
to change, and possess an ability to effectively multi-task.
Opportunity for learning and growth is available within the group
and throughout NAMSA.
Day-to-day responsibilities include:
Leads multidisciplinary clinical projects by managing the
above-listed tasks for simple to moderately complex studies.
Effectively manages cross-functional groups.
Understands investigational product(s) including high-level
understanding of the Medical Device Development Process.
Reviews monitoring reports.
Conducts and summarizes literature searches according to applicable
Assists in planning and conduct of site and sponsor clinical
Assists with FDA/competent authority inspections, sponsor/vendor
audits of NAMSA.
Organizes and manages Investigator Meetings.
Selects and manages Core Laboratories.
Safety committee (e.g. DSMB or CEC) selection and management.
Bachelor's degree or equivalent experience in a related field, with
a minimum 3 years of current monitoring (preferred) and relevant
clinical trial experience; and
Knowledge of Good Clinical Practices in US and Europe.
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 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.
Understanding of site escalation process for compliance issues.
Multidiscipline (at least 2 specialties) 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.
Project management experience with at least 1 complex multicenter
Fluency in English and local language, if different, required.
Knowledge and experience with applicable standards and regulations
for medical device trials.
NAMSA is a responsive employer offering competitive benefits
packages, exceptional training, opportunities for growth, and more
- wrapped up in a meaningful career. Please apply with your
LinkedIn profile for a thorough review and a possible phone
*More job description detail is provided on the NAMSA Careers page:
Position descriptions are not intended, and should not be construed
to be an exhaustive list of all responsibilities, skills, and
efforts or working conditions associated with a job. NAMSA reserves
the right to revise duties as needed.
Keywords: NAMSA, St. Louis , Clinical Study Manager - 100% Remote, US, Executive , Saint Louis, Missouri
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