Clinical Operations Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee assigned clinical studies from the feasibility phase and initiation through enrollment, execution, database closure, and finalization.

• Maintain comprehensive study plans, timelines, deliverables, and action items.

• Coordinate the development of protocols, informed consent documents, study manuals, monitoring strategies, safety management plans, and essential documentation.

• Manage site selection, qualification, activation, recruitment, retention, enrollment forecasting, and site performance evaluation.

• Directly address and resolve operational challenges.

• Facilitate study team meetings, compile status reports and executive dashboards, monitor decisions, and escalate significant risks along with suggested solutions.

• Create and uphold project timelines, trackers, risk/issue/dependency logs, and accountability for deliverables.

• Prepare and manage study budgets, track purchase orders and contracts, create forecasts, reconcile invoices, assess change orders, and generate quarterly expenditure reports.

• Coordinate CRO and vendor deliverables, assess KPIs and service levels, review monitoring outcomes, and implement corrective actions.

• Assist with site budgets, payment timelines, vendor onboarding, coordination of study supplies, logistics for investigational device shipments, and resource allocation.

• Conduct both remote and on-site qualifications, initiations, interim monitoring, and closeout visits.

• Evaluate informed consent, eligibility, protocol compliance, source documentation, CRF/eCRF entries, investigational device accountability, and safety records.

• Perform risk-based source data reviews and verifications, address data inquiries, reconcile inconsistencies, and document monitoring results.

• Maintain communication with site contacts and provide training and support to coordinators and investigators regarding study procedures, EDC systems, device utilization, and escalation of issues.

• Monitor site and sponsor TMF/eTMF completeness, document quality, and readiness for inspections; address any identified gaps.

• Assist in the identification, documentation, reconciliation, and escalation of adverse events, serious adverse events, device deficiencies, product complaints, and protocol deviations.

• Collaborate with Medical, Regulatory, and Quality teams on safety assessments, reportability decisions, deviation trends, CAPA activities, and readiness for inspections.

• Ensure compliance with ISO 14155, ICH GCP, 21 CFR Parts 50, 54, 56, and 812, privacy regulations, and international standards.

• Collaborate with Data Management and Biostatistics on data cleaning, query resolution, database closure, study finalization, audits, and inspections.

⛳️ Requirements

• Bachelor's degree in nursing, life sciences, healthcare, or a related field, or equivalent experience.

• Minimum of 7 years of progressive experience in clinical research.

• Significant CRA monitoring experience.

• Experience in managing clinical trials.

• Proven experience executing medical device studies.

• Experience engaging directly with investigational sites, CROs, and vendors.

• Capability to manage timelines, budgets, monitoring deliverables, essential documents, risk tracking, and study reporting.

• Familiarity with ISO 14155, FDA device clinical investigation standards, GCP, informed consent protocols, safety escalation, and TMF/eTMF management.

• Excellent writing, organizational, prioritization, problem-solving, and communication skills.

• Willingness to travel as required.

• Experience with respiratory or sleep device studies, home-use devices, or connected/remote data collection.

• Experience supporting both U.S. and European studies, including GDPR compliance and post-market clinical follow-up activities.

• Proficiency in EDC systems such as REDCap and Medidata Rave.

• Proficiency in eTMF systems such as MasterControl.

• Experience in Excel for forecasting and project dashboards.

• Experience in supporting reimbursement-focused evidence generation, enrollment recovery, and efficient 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 matching.

• Generous paid vacation leave.

• Paid sick leave.

• Paid volunteer time.