Clinical Operations Manager

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $121k - $146k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

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Inogen

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2001

🏥 Healthcare

💼 Consulting

🎖️ Defense

💰 $20M Venture Round on 2012-04

Healthcare • Consulting • Defense

Inogen is a global leader in portable oxygen technology, dedicated to innovating and improving oxygen concentrators for better patient outcomes. Since 2001, Inogen has developed multiple generations of portable oxygen concentrators (POCs), each more powerful and efficient than the last. The company's POC solutions provide flexibility and mobility to patients with oxygen therapy needs, with products offering significant battery life and ease of use. Inogen's devices are backed by peer-reviewed clinical research, ensuring their effectiveness and reliability. With a presence in over 59 countries, Inogen remains at the forefront of the global oxygen therapy market through its commitment to quality and patient-centric design.

📋 Description

• Manage assigned clinical studies from feasibility and start-up through enrollment, conduct, database lock, and closeout • Maintain integrated study plans, milestones, deliverables, and action logs • Coordinate protocol, informed consent forms, study manuals, monitoring plans, safety management plans, and essential document development • Oversee site selection, qualification, activation, recruitment, retention, enrollment forecasting, and site performance • Resolve 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 • 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 • 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 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 • 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 regarding 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, privacy requirements, and international requirements • Partner with Data Management and Biostatistics on data cleaning, query resolution, database lock, study closeout, audits, and inspections

🎯 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 • Substantial CRA monitoring experience • Clinical trial management responsibility • Experience executing medical device studies • Experience working directly with investigational sites, CROs, and vendors • 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 • Experience with respiratory or sleep device studies, home-use devices, or connected-device/remote-use data collection • Experience supporting both U.S. and European studies, including GDPR and post-market clinical follow-up activities • Proficiency with EDC systems such as REDCap and Medidata Rave • Proficiency with eTMF systems such as MasterControl • Excel forecasting and project dashboards experience • Experience supporting reimbursement-focused evidence generation, enrollment recovery, and lean sponsor-side operations

🏖️ Benefits

• Annual performance bonus incentive plan • Company-sponsored benefits • Wellbeing programs • Health insurance • Dental insurance • Vision insurance • 401(k) plan with employer contribution and match • Generous paid vacation leave • Paid sick leave • Paid volunteer time

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