Clinical Study Manager - 100% Remote, US

Company: NAMSA
Location: Saint Louis
Posted on: May 16, 2022

Job Description:

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 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 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 requirements.
Assists in planning and conduct of site and sponsor clinical audits.
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.

Minimum Requirements:
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 US/OUS trial.
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 discussion.

*More job description detail is provided on the NAMSA Careers page: https://namsa.wd5.myworkdayjobs.com/en-US/NAMSA/job/Remote---USA/Clinical-Study-Manager--100--Remote-_R2369

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