Compensation Target:

$115,000.00

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:
oEstablishes and monitors project metrics
oTracks project deliverables
oCommunicates project status to clients and internal teams
oFacilitates team and sponsor meetings
oFollows cross-functional team action items to resolution
• Drives all site activities from start-up through close-out:
oSite selection and qualification
oIRB/IEC/REB/REC submissions and any additionally required submissions (e.g., radiation, NIHR, etc.)
oRegulatory document collection and review
oBudget and contract negotiations
oSite initiation (on-site or remote training, follow-up, activation)
oProvides site training, when necessary
oScreening and enrollment
oMonitors 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
oInvestigator site file maintenance
oWorks with CTAs to ensure sites have all materials necessary to conduct study
oSite engagement activities (recruitment strategies, coordinator calls, newsletters, trainings, etc.)
oManages monitoring activities (e.g., scheduling, follow-up, action item resolution, etc.)
oMonitors quality, frequency and appropriate documentation of site communications
oTroubleshoots site and team issues; considers and potentially implements CAPAs
oSupports 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:
oEnsures 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
oEnsures Trial Master File quality and overall audit readiness at study and site levels
oAssists with the development, testing and implementation of study systems: EDC, CTMS, TMF, device accountability, etc.
oWorks with data management/biostatistics to develop reports and listings for centralized review of data; reviews data, spots trends to ensure quality of data.
oAssists in the submission and review of all clinical deliverables for regulatory submissions (e.g., FDA, National Competent Authorities, etc.)
oDevelops 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 clini cal 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.
• Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.

Working Conditions:
• 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.

The compensation grade range for this position is:
$68,800.00 - $133,700.00

Annual

Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.