Clinical Study Manager LOOKING FOR Clinical Study Manager JOB AT Remote

• Mission is to make a scientific contribution to every medical device in the world.
• Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
• Values have stood the test of time.
• Above all else, conduct ourselves with integrity

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.

• Establishes and ensures commitments are met for the client.
• Provides direction and priorities to internal team members.
• Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
• Handles challenging situations, and knows when to call-in help.
• Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Performs project in compliance with regulations.
• Delivers presentations, including preparation, assembling slides, and speaking.
• Provides feedback regarding project team members using the appropriate performance management tools and processes, in a timely manner.

• Mentors CRAs and CSMs

• Proposes and implements systems and processes to support internal improvement and NAMSA’s long-term growth.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.
• Travels as needed (typically between 20-30%) to meet project milestones.