Clinical Study Manager

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.