Clinical Operations Manager

Inogen

. Manage assigned clinical studies from feasibility and start-up through enrollment, conduct, database lock, and closeout .

Posted 11/6/2026full-timeRemote • United StatesSeniorLead💰 $121,000 - $146,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing clinical studies, including oversight of timelines, budgets, and compliance with regulatory standards such as ISO 14155 and ICH GCP. Proficient in coordinating with CROs, vendors, and investigational sites while ensuring data integrity and safety management.

Highest-signal resume keywords

Clinical Trial ManagementCRA Monitoring ExperienceISO 14155 ComplianceEDC Systems ProficiencyBudget Development and Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceMedical Device Studies ExecutionRisk TrackingData CleaningMonitoring DeliverablesEnrollment ForecastingProtocol AdherenceSource Data ReviewTMF/eTMF ManagementChange-Order Assessments

Soft Skills

Strong Writing SkillsOrganizationPrioritizationProblem-SolvingCommunication Skills

Tools & Technologies

REDCapMedidata RaveMasterControlExcel Project Dashboards

Industry Keywords

Clinical ResearchInvestigational SitesCROsFDA Device Clinical InvestigationGDPR CompliancePost-Market Clinical Follow-UpHome-Use DevicesConnected-Device Data Collection

About the role

Key responsibilities & impact

Manage assigned clinical studies from feasibility and start-up through enrollment, conduct, database lock, and closeout
Maintain integrated study plans, milestones, deliverables, and action logs
Coordinate protocol, informed consent forms, study manuals, monitoring plans, safety management plans, and essential document development
Oversee site selection, qualification, activation, recruitment, retention, enrollment forecasting, and site performance
Resolve operational barriers directly
Lead study team meetings, prepare status reports and executive dashboards, track decisions, and escalate critical risks with proposed solutions
Build and maintain project schedules, trackers, risk/issue/dependency logs, and deliverable accountability
Develop and maintain study budgets, purchase order and contract trackers, forecasts, invoice reconciliation, change-order assessments, and quarterly spend reports
Coordinate CRO and vendor deliverables, monitor KPIs and service levels, review monitoring outputs, and drive corrective actions
Support site budgets, payment schedules, vendor onboarding, study supply coordination, investigational device shipment logistics, and resource planning
Perform remote and on-site qualification, initiation, interim monitoring, and closeout visits
Review informed consent, eligibility, protocol adherence, source documentation, CRF/eCRF entries, investigational device accountability, and safety documentation
Conduct risk-based source data review and verification, follow up on data queries, reconcile discrepancies, and document monitoring findings
Maintain site contact and train and support coordinators and investigators on study procedures, EDC systems, device usage, and issue escalation
Track site and sponsor TMF/eTMF completeness, document quality, and inspection readiness; remediate gaps
Support identification, documentation, reconciliation, and escalation of adverse events, serious adverse events, device deficiencies, product complaints, and protocol deviations
Coordinate with Medical, Regulatory, and Quality teams regarding safety assessments, reportability decisions, deviation trends, CAPA activities, and inspection readiness
Ensure compliance with ISO 14155, ICH GCP, 21 CFR Parts 50, 54, 56, and 812, privacy requirements, and international requirements
Partner with Data Management and Biostatistics on data cleaning, query resolution, database lock, study closeout, audits, and inspections

Requirements

What you’ll need

Bachelor’s degree in nursing, life sciences, healthcare, or a related discipline, or equivalent experience
At least 7 years of progressive clinical research experience
Substantial CRA monitoring experience
Clinical trial management responsibility
Experience executing medical device studies
Experience working directly with investigational sites, CROs, and vendors
Ability to manage timelines, budgets, monitoring deliverables, essential documents, risk tracking, and study reporting
Working knowledge of ISO 14155, FDA device clinical investigation requirements, GCP, informed consent, safety escalation, and TMF/eTMF management
Strong writing, organization, prioritization, problem-solving, and communication skills
Willingness to travel
Experience with respiratory or sleep device studies, home-use devices, or connected-device/remote-use data collection
Experience supporting both U.S. and European studies, including GDPR and post-market clinical follow-up activities
Proficiency with EDC systems such as REDCap and Medidata Rave
Proficiency with eTMF systems such as MasterControl
Excel forecasting and project dashboards experience
Experience supporting reimbursement-focused evidence generation, enrollment recovery, and lean sponsor-side operations

Benefits

Comp & perks

Annual performance bonus incentive plan
Company-sponsored benefits
Wellbeing programs
Health insurance
Dental insurance
Vision insurance
401(k) plan with employer contribution and match
Generous paid vacation leave
Paid sick leave
Paid volunteer time