Clinical Trial Manager

Description

Position Summary

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.

Key Responsibilities

Study Execution & Delivery

• 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

Operational Oversight

• 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

CRO & Vendor Management

• 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

Regulatory & Compliance

• 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)

Data Quality & TMF Oversight

• 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

Cross-Functional Collaboration

• Partner with:
  • Medical Affairs
  • Quality Assurance
  • Regulatory Affairs
  • Marketing / Market Access
• Support clinical strategies aligned with CMS reimbursement

Budget & Resource Support

• Track study budgets and forecasts
• Support site budgets and FMV alignment
• Escalate resourcing gaps as needed

Qualifications

Required

• 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)
  • FDA clinical trial regulations
• Experience working with CROs and vendors

Preferred

• 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
  • MasterControl or Veeva eTMF

Core Competencies

• Strong execution and operational ownership
• Ability to work in a fast-paced, lean environment
• Effective communication and stakeholder coordination
• Problem-solving and risk awareness
• Attention to quality and compliance

Leveling

• Manages studies of moderate complexity
• Executes plans with some oversight