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

NAMSA

About The Position

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 and the Mission to deliver best-in-class global MedTech 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. 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 metrics o Tracks project deliverables o Communicates project status to clients and internal teams o Facilitates team and sponsor meetings o Follows cross-functional team action items to resolution • Drives all site activities from start-up through close-out: o Site selection and qualification o IRB/IEC/REB/REC submissions and any additionally required submissions (e.g., radiation, NIHR, etc.) o Regulatory document collection and review o Budget and contract negotiations o Site initiation (on-site or remote training, follow-up, activation) o Provides site training, when necessary o Screening and enrollment o 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 o Investigator site file maintenance o Works with CTAs to ensure sites have all materials necessary to conduct study o 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 communications o Troubleshoots site and team issues; considers and potentially implements CAPAs o 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 necessary o Ensures Trial Master File quality and overall audit readiness at study and site levels o Assists with the development, testing and implementation of study systems: EDC, CTMS, TMF, device accountability, etc. o Works with data management/biostatistics to develop reports and listings for centralized review of data; reviews data, spots trends to ensure quality of data. o Assists in the submission and review of all clinical deliverables for regulatory submissions (e.g., FDA, National Competent Authorities, etc.) o 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.

Requirements

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.

Nice To Haves

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

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: o Establishes and monitors project metrics o Tracks project deliverables o Communicates project status to clients and internal teams o Facilitates team and sponsor meetings o Follows cross-functional team action items to resolution
Drives all site activities from start-up through close-out: o Site selection and qualification o IRB/IEC/REB/REC submissions and any additionally required submissions (e.g., radiation, NIHR, etc.) o Regulatory document collection and review o Budget and contract negotiations o Site initiation (on-site or remote training, follow-up, activation) o Provides site training, when necessary o Screening and enrollment o 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 o Investigator site file maintenance o Works with CTAs to ensure sites have all materials necessary to conduct study o 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 communications o Troubleshoots site and team issues; considers and potentially implements CAPAs o 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 necessary o Ensures Trial Master File quality and overall audit readiness at study and site levels o Assists with the development, testing and implementation of study systems: EDC, CTMS, TMF, device accountability, etc. o Works with data management/biostatistics to develop reports and listings for centralized review of data; reviews data, spots trends to ensure quality of data. o Assists in the submission and review of all clinical deliverables for regulatory submissions (e.g., FDA, National Competent Authorities, etc.) o 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.