Description Clinical Operations ManagerTravel: As required for site monitoring and study activities
Position SummaryInogen's growing Clinical Affairs team is seeking a versatile and adaptable, hands-on Clinical Operations Manager to execute and oversee clinical studies across its respiratory medical device portfolio, including airway clearance and mask technologies. The responsibilities of this role include various aspects of clinical trial management and execution, including but not limited to study project coordination, vendor engagement and management, and monitoring visits.
The successful candidate will be equally comfortable setting study plans, managing vendors and budgets, and directly supporting sites through monitoring, documentation review, issue resolution, and closeout.
The position requires strong individual ownership, team collaboration, practical judgment, and the ability to shift between strategic coordination and day-to-day execution in a lean, agile, fast-moving clinical organization. The individual will work independently while partnering closely with Medical Affairs, Marketing, R&D, Regulatory Affairs, Quality, Data Management, and external study partners.
Key ResponsibilitiesClinical Trial Management and Study Execution- Manage assigned 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 with functional owners.
- Oversee site selection, qualification, activation, recruitment, retention, enrollment forecasting, and site performance; intervene directly to resolve operational barriers.
- Lead study team meetings, prepare status reports and executive dashboards, track decisions, and escalate critical risks with proposed solutions.
Project Management, Budget, and Vendor Oversight- Build and maintain project schedules, trackers, risk/issue/dependency logs, and accountability for deliverables across internal teams, CROs, sites, and vendors.
- 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 timely corrective actions.
- Support site budgets, payment schedules, vendor onboarding, study supply coordination, investigational device shipment logistics, and resource planning.
Hands-on Site Monitoring Responsibilities- Perform remote and on-site qualification, initiation, interim monitoring, and closeout visits, including preparation, conduct, reporting, and follow-up.
- 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 regular site contact; 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 when appropriate.
Other Responsibilities- 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, as well as privacy and international requirements.
- Partner with Data Management and Biostatistics on data cleaning, query resolution, database lock, study closeout, audits, and inspections.
Required Qualifications- Bachelor's degree in nursing, life sciences, healthcare, or a related discipline, or equivalent experience.
- At least 7 years of progressive clinical research experience, including substantial CRA monitoring experience and clinical trial management responsibility.
- Experience executing medical device studies and working directly with investigational sites, CROs, and vendors.
- Demonstrated 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, communication skills, and willingness to travel.
Preferred Qualifications- 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 (e.g., REDCap, Medidata Rave), eTMF systems (e.g., MasterControl), Excel forecasting, and project dashboards.
- Experience supporting reimbursement-focused evidence generation, enrollment recovery, and lean sponsor-side operations.
Core Competencies and Measures of Success- Adaptability: Transition effectively among CTM, PM, and CRA responsibilities.
- Accountability: Deliver accurate and timely milestones, reports, forecasts, and issue resolution.
- Site and Vendor Performance: Improve enrollment, data quality, monitoring follow-up, and responsiveness.
- Inspection Readiness: Maintain complete, traceable records and timely escalation of compliance issues.
- Communication: Provide concise, decision-ready updates to leadership and stakeholders.
Role Scope and Operating ExpectationsThis is a hands-on individual contributor role with broad operational responsibility in a growing and evolving Clinical Affairs function. It is neither solely a Clinical Trial Manager position nor solely a field CRA role. Flexibility, adaptability, and a team-oriented mindset are essential.
Assignments and travel will be prioritized based on study risk, workload, and business needs. Specialized medical judgment, regulatory sign-off, statistical analysis, and independent Quality Assurance oversight remain with appropriately qualified functional owners. Additional support or CRO resources may be assigned when study volume or monitoring demand exceeds feasible capacity.
DisclaimerThe above statements are intended to describe the general nature and level of work being performed by personnel assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Inogen assesses market data to ensure a competitive compensation package for our employees. The base salary for this position is expected to be between $121,000.00 and $146,000.00 annually. However, actual base salary if hired will be determined on an individualized basis and will be based on non-discriminatory factors, including as to individual skills, education, experience and market location.
Our Benefits and Rewards:
In addition to the expected base salary, this role is eligible to participate in Inogen's annual performance bonus incentive plan, highly competitive and company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provides health, dental, and vision insurance, 401(k) plan plus employer contribution and match, and generous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter.
