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NAMSA · 1 day ago

Clinical (CRO) Operations (CRA, CFS, CSM, CDM) (NAMSA Talent Building Community)

United States

Full-time

Onsite

Mid Level

3+ years exp

NAMSA is a pioneering company focused on medical device materials for safety, shaping the industry since 1976. They are seeking a Clinical Study Manager responsible for the timely execution and high-quality implementation of clinical study activities, ensuring compliance with industry standards and regulatory requirements.

Medical Device

Responsibilities

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:

Establishes and monitors project metrics

Tracks project deliverables

Communicates project status to clients and internal teams

Facilitates team and sponsor meetings

Follows cross-functional team action items to resolution

Drives all site activities from start-up through close-out:

Site selection and qualification

IRB/IEC/REB/REC submissions and any additionally required submissions (e.g., radiation, NIHR, etc.)

Regulatory document collection and review

Budget and contract negotiations

Site initiation (on-site or remote training, follow-up, activation)

Provides site training, when necessary

Screening and enrollment

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 deviations

Investigator site file maintenance

Works with CTAs to ensure sites have all materials necessary to conduct study

Site engagement activities (recruitment strategies, coordinator calls, newsletters, trainings, etc.)

Manages monitoring activities (e.g., scheduling, follow-up, action item resolution, etc.)

Monitors quality, frequency and appropriate documentation of site communications

Troubleshoots site and team issues; considers and potentially implements CAPAs

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:

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 necessary

Ensures Trial Master File quality and overall audit readiness at study and site levels

Assists with the development, testing and implementation of study systems: EDC, CTMS, TMF, device accountability, etc

Works with data management/biostatistics to develop reports and listings for centralized review of data; reviews data, spots trends to ensure quality of data

Assists in the submission and review of all clinical deliverables for regulatory submissions (e.g., FDA, National Competent Authorities, etc.)

Develops clinical study report

General project compliance: ensures that adherence to industry standards and regulatory requirements, including but not exclusive to contractual agreements, department guidelines, SOPs, applicable international, Federal and State regulations, and ICH Guidelines

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

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

Qualification

Clinical trial experienceClinical PracticesProject managementMedical device regulationsData management understandingBiostatistics understandingMultidiscipline therapeutic knowledgeSoCRAACRP CertificationFluency in EnglishPresentation skillsCommunication skills

Required

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

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

Preferred

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