Clinical Study Manager

NAMSA

. Develop and maintain foundational clinical study materials and tools .

Posted 10/2/2026full-timeRemote • United StatesMid-LevelSenior💰 $83,500 - $162,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing clinical trials, including project management, compliance with Good Clinical Practices, and effective communication with multidisciplinary teams. Proficient in developing clinical study materials, monitoring data quality, and ensuring audit readiness.

Highest-signal resume keywords

Clinical Trial ManagementProject Management ExperienceGood Clinical Practices KnowledgeData Management UnderstandingRegulatory Compliance

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Study DevelopmentStudy Tracking Tools ManagementProtocol Training SupportAdverse Events MonitoringClinical Study Reports DevelopmentData Quality MonitoringSite Compliance ManagementBiostatistics UnderstandingClinical Trial Data RequirementsMultidiscipline Therapeutic Knowledge

Soft Skills

Effective CommunicationTeam CoordinationProblem-SolvingPresentation SkillsFacilitation of Meetings

Tools & Technologies

EDC SystemsCTMSTMFDevice-Accountability Systems

Certifications & Qualifications

SoCRA CertificationACRP Certification

Industry Keywords

Clinical TrialsMedical Device DevelopmentSOPsICH GuidelinesRegulatory SubmissionsInvestigator MeetingsSite SelectionMonitoring ReportsCAPAsSafety Committees

About the role

Key responsibilities & impact

Develop and maintain foundational clinical study materials and tools
Coordinate team and client review processes
Create and manage study tracking tools, metrics, systems, and reporting
Support protocol training, client and site management, and escalation and resolution of site issues
Establish and monitor project metrics and track project deliverables
Communicate project status to clients and internal teams
Facilitate team and sponsor meetings and follow action items to resolution
Drive site activities from start-up through close-out, including site selection, qualification, submissions, document collection, contracting, initiation, enrollment, monitoring, engagement, and close-out
Monitor data quality, site compliance, adverse events, protocol deviations, and site communications
Troubleshoot site and team issues and potentially implement CAPAs
Drive project-level deliverables and maintain current, consistent project plans and TMF-level documents
Ensure Trial Master File quality and audit readiness
Assist with development, testing, and implementation of EDC, CTMS, TMF, and device-accountability systems
Work with data management and biostatistics to develop reports and listings and review data trends
Assist with clinical deliverables for regulatory submissions
Develop clinical study reports
Ensure compliance with contractual agreements, SOPs, ICH Guidelines, and applicable regulations
Lead multidisciplinary clinical projects for simple to moderately complex studies
Manage cross-functional groups
Understand investigational products and the medical device development process
Review monitoring reports
Conduct and summarize literature searches
Assist with clinical audits, regulatory inspections, and sponsor/vendor audits
Organize and manage Investigator Meetings
Select and manage Core Laboratories
Select and manage safety committees such as DSMB or CEC

Requirements

What you’ll need

Bachelor’s degree or equivalent experience in a related field
Minimum 3 years of relevant clinical trial and/or monitoring experience
Project management experience
Fluency in English and local language, if different
Knowledge of Good Clinical Practices
Knowledge of regulations applicable to medical device trials at various development stages
Familiarity with the clinical trial process
Understanding of site escalation processes for compliance issues
Multidiscipline therapeutic knowledge in at least 2 therapeutic areas
Familiarity with medical device development from pre-clinical to commercialization
Understanding of data management and biostatistics in clinical trials
Understanding of clinical trial data requirements and presentation
Ability to communicate effectively with physicians, health care workers, study coordinators, and IRB/EC/REB personnel
Ability to prepare slides and present complex information professionally and clearly
SoCRA or ACRP certification preferred but not required
Ability to meet the physical demands of the role, including occasional lifting of up to 25 pounds
Extensive computer keyboard use
Ability to travel 20-30% as needed

Benefits

Comp & perks

Compensation target of $115,000.00
Travel as needed (typically between 20-30%)
Reasonable accommodations for individuals with disabilities
Equal employment opportunity
Pre-employment background and drug screen processes aligned to local, state and federal laws