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 Med Tech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global Med Tech 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.

Compensation Target:$

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.):
• Develops and maintains foundational study materials and tools (protocol with study design, training slides, informed consent, investigator brochure, instructions for use, templates, forms, SOPs, processes, etc.), and coordinates team and client review processes.
• Creates and manages study tracking tools (metrics, systems, reporting).
• Supports internal clinical team members: protocol training, client and site management and oversight, escalation and resolution of site issues.
• In collaboration with Project Management, supports all project-level duties:o Establishes and monitors project metricso Tracks project deliverable so Communicates project status to clients and internal teamso Facilitates team and sponsor meetingso Follows cross-functional team action items to resolution
• Drives all site activities from start-up through close-out:o Site selection and qualificationo IRB/IEC/REB/REC submissions and any additionally required submissions (e.g., radiation, NIHR, etc.)o Regulatory document collection and reviewo Budget and contract negotiation so Site initiation (on-site or remote training, follow-up, activation) o Provides site training, when necessaryo Screening and enrollmento Monitors notable trends/potential issues in data entry (quality and completion), general site compliance to the protocol, GCP, SOP, and other applicable guidelines, adverse events, protocol deviation so Investigator site file maintenanceo Works with CTAs to ensure sites have all materials necessary to conduct studyo Site engagement activities (recruitment strategies, coordinator calls, newsletters, trainings, etc.)o

Manages monitoring activities (e.g., scheduling, follow-up, action item resolution, etc.)o Monitors quality, frequency and appropriate documentation of site communication so Troubleshoots site and team issues; considers and potentially implements CAPAso Supports close-out efforts by ensuring all data and regulatory action items are adequately resolved, investigator responsibilities relayed, IRB/EC reporting complete.
• In collaboration with relevant functional groups, drives all project-level deliverables:o Ensures project plans and other TMF level documents are current and consistent (data management plan, system specifications, safety and core lab manuals, etc.); initiates and coordinates revisions, when necessaryo Ensures…