NAMSA

Clinical Research

• 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 Monitors 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. Qualifications & Technical Competencies: • 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 the 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. • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.

Clinical Study Manager

Compliance

Sets the strategic philosophy and direction for NAMSA’s global quality and regulatory compliance systems applicable to all functions and entities.
Owns the quality direction including the research, monitoring and communication of current and changing regulations including applicable laws and guidelines.(e.g., US and ex-US GxPs, ISO requirements).
Develops and maintains external relationships with key opinion leaders, medical directors and regulatory officials.
Designs and implements systems and controls to ensure consistency and compliance with applicable regulatory requirements, across the global NAMSA network.
Selects, trains, and supervises staff to perform quality engineering, quality assurance, quality systems and quality/regulatory compliance functions consistent with strategic plans for ongoing implementation of the NAMSA Quality Policy.
Oversees the Corporate Quality System ensuring compliance with all national and international standards and regulations, including but not limited to US FDA, CFDA and applicable ISO standards for the Company.
Develops and directs the internal quality system support functions for NAMSA, including Document Control, Archives/Records, Training, CAPA, Complaints, Management Review, Business Software Validations, Internal/External compliance Audits, Supplier Approval and Supplier Audits, Quality Engineering, and GxP Quality Data Audit/Review/Approval.
Works cooperatively with NAMSA Leaders to implement programs to improve overall quality and increase regulatory compliance. Assures test validation and audits accurately assesses ongoing performance and detects quality problems. Promptly notify management of significant quality system or technical problems.
Directs and accomplishes financial objectives for the Quality organization by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions; effective utilization of resources, equipment (engineering) and space.
Acts as the primary interface with the US FDA and other regulatory authorities globally for compliance inspections.
Develops and maintains a three-year staffing and space requirement plan.
Advises and assists clients regarding quality and regulatory concerns.

Clinical Study Manager

Vice President, Global Quality and Regulatory Compliance