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
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 $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.