Clinical Trial Manager

Clinical Trial ManagerInogen is seeking a Clinical Trial Manager to support the execution of clinical studies across our respiratory medical device portfolio, including airway clearance devices and next-generation mask technologies.This role is critical to advancing clinical evidence generation supporting CMS reimbursement, post-market surveillance, and regulatory strategies. The CTM will operate in a hands-on, fast-paced environment and is responsible for delivering high-quality clinical studies in compliance with ISO 14155, ICH E6 (R3), and FDA regulations.Study Execution & DeliverySupport end-to-end execution of clinical studies (start-up through closeout), including: Post-market clinical follow-up (PMCF/PMS)Non-significant risk (NSR) device studiesExecute study timelines, milestones, and deliverablesSupport site activation, enrollment, and retention effortsOperational OversightManage day-to-day study activities across sites, CROs, and vendorsMaintain clinical trial trackers, dashboards, and risk logsIdentify and escalate study risks (e.g., enrollment delays, data quality issues)Ensure protocol adherence and high-quality data collectionCRO & Vendor ManagementSupport oversight of CROs and vendorsTrack performance against deliverables and timelinesAssist with TMF completeness and monitoring qualityReview invoices for accuracy and alignment with scopeRegulatory & ComplianceEnsure compliance with: ISO 1415521 CFR (50, 54, 56, 812)Support Regulatory in IDE pathways and study requirementsMaintain inspection readiness (FDA BIMO, notified bodies)Data Quality & TMF OversightSupport data integrity and completeness (e.g., REDCap, EDC systems)Maintain TMF quality and inspection readiness (e.g., MasterControl, Veeva)Collaborate with Biostatistics and Data Management on: Data cleaningDatabase lock activitiesCross-Functional CollaborationPartner with: Medical AffairsQuality AssuranceRegulatory AffairsMarketing / Market AccessSupport clinical strategies aligned with CMS reimbursementBudget & Resource SupportTrack study budgets and forecastsSupport site budgets and FMV alignmentEscalate resourcing gaps as neededRequiredBachelor's degree in Life Sciences, Nursing, or related field8+ years of clinical research experience, with 13 years experience as a Clinical Trial ManagerExperience managing medical device clinical trialsStrong knowledge of: ISO 14155 or ICH E6 (R3)FDA clinical trial regulationsExperience working with CROs and vendorsPreferredExperience in respiratory or pulmonary devicesExposure to CMS reimbursement-driven studiesFamiliarity with EU clinical studies and GDPRExperience with: REDCap or Medidata RaveMasterControl or Veeva eTMFCore CompetenciesStrong execution and operational ownershipAbility to work in a fast-paced, lean environmentEffective communication and stakeholder coordinationProblem-solving and risk awarenessAttention to quality and complianceLevelingManages studies of moderate complexityExecutes plans with some oversightInogen 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 $141,000.00 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. Inogen is an Equal Employment Opportunity/Affirmative Action Employer - Underrepresented racial and ethnic groups/Females/Individuals with Disabilities/Protected Veterans.