Clinical Operations Manager

Inogen

7d•$121,000 - $146,389

About The Position

Inogen’s Clinical Affairs team is seeking a hands-on Clinical Operations Manager to execute and oversee clinical studies across its respiratory medical device portfolio, including airway clearance and mask technologies. The role spans study project coordination, vendor engagement and management, and monitoring visits. The successful candidate will develop study plans, manage vendors and budgets, and support sites through monitoring, documentation review, issue resolution, and closeout. This is a hands-on individual contributor role with broad operational responsibility in a growing, evolving Clinical Affairs function. The position requires independent ownership, collaboration, practical judgment, and the ability to shift between strategic coordination and day-to-day execution. The manager will work closely with Medical Affairs, Marketing, R&D, Regulatory Affairs, Quality, Data Management, and external study partners. Travel is required as needed for site monitoring and study activities, with assignments prioritized according to study risk, workload, and business needs.

Requirements

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, and communication skills.
Willingness to travel as required for site monitoring and study activities.
Ability to work independently and collaboratively, adapt among CTM, PM, and CRA responsibilities, and operate in a lean, evolving clinical organization.

Nice To Haves

Experience with respiratory or sleep device studies, home-use devices, or connected-device/remote-use data collection.
Experience supporting U.S. and European studies, including GDPR and post-market clinical follow-up activities.
Proficiency with EDC systems such as REDCap or Medidata Rave, eTMF systems such as MasterControl, Excel forecasting, and project dashboards.
Experience supporting reimbursement-focused evidence generation, enrollment recovery, and lean sponsor-side operations.

Responsibilities

Manage assigned studies from feasibility and start-up through enrollment, conduct, database lock, and closeout; maintain study plans, milestones, deliverables, and action logs.
Coordinate development of protocols, informed consent forms, study manuals, monitoring plans, safety management plans, and essential documents with functional owners.
Oversee site selection, qualification, activation, recruitment, retention, enrollment forecasting, and site performance; address operational barriers directly.
Lead study team meetings, prepare status reports and executive dashboards, track decisions, and escalate critical risks with proposed solutions.
Build and maintain project schedules, trackers, risk/issue/dependency logs, and deliverable accountability 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 corrective actions.
Support site budgets, payment schedules, vendor onboarding, study supply coordination, investigational device shipment logistics, and resource planning.
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 and 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.
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 on 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, and applicable privacy and international requirements.
Partner with Data Management and Biostatistics on data cleaning, query resolution, database lock, study closeout, audits, and inspections.
Provide concise, decision-ready updates to leadership and stakeholders and support timely issue resolution.