Clinical Trial Manager

Inogen

2d

About The Position

Inogen is seeking a Clinical Trial Manager (CTM) 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.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, or related field
• 8+ years of clinical research experience, with 1–3 years experience as a Clinical Trial Manager
• Experience managing medical device clinical trials
• Strong knowledge of: ISO 14155 or ICH E6 (R3)
• Strong knowledge of: FDA clinical trial regulations
• Experience working with CROs and vendors

Nice To Haves

• Experience in respiratory or pulmonary devices
• Exposure to CMS reimbursement-driven studies
• Familiarity with EU clinical studies and GDPR
• Experience with: REDCap or Medidata Rave
• Experience with: MasterControl or Veeva eTMF

Responsibilities

• Support end-to-end execution of clinical studies (start-up through closeout), including: Post-market clinical follow-up (PMCF/PMS), Non-significant risk (NSR) device studies
• Execute study timelines, milestones, and deliverables
• Support site activation, enrollment, and retention efforts
• Manage day-to-day study activities across sites, CROs, and vendors
• Maintain clinical trial trackers, dashboards, and risk logs
• Identify and escalate study risks (e.g., enrollment delays, data quality issues)
• Ensure protocol adherence and high-quality data collection
• Support oversight of CROs and vendors
• Track performance against deliverables and timelines
• Assist with TMF completeness and monitoring quality
• Review invoices for accuracy and alignment with scope
• Ensure compliance with: ISO 14155, 21 CFR (50, 54, 56, 812)
• Support Regulatory in IDE pathways and study requirements
• Maintain inspection readiness (FDA BIMO, notified bodies)
• Support 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 cleaning, Database lock activities
• Partner with: Medical Affairs, Quality Assurance, Regulatory Affairs, Marketing / Market Access
• Support clinical strategies aligned with CMS reimbursement
• Track study budgets and forecasts
• Support site budgets and FMV alignment
• Escalate resourcing gaps as needed

Benefits

• annual performance bonus incentive plan
• company-sponsored benefits
• wellbeing programs
• health insurance
• dental insurance
• vision insurance
• 401(k) plan plus employer contribution and match
• generous paid leaves such as vacation and sick leave
• paid volunteer time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level