Senior Manager, Clinical Oversight Monitoring
4D Molecular Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $134,000 - $178,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Execute oversight activities in alignment with the Clinical Oversight Monitoring Plan and related SOPs.
- Partner with the Associate Director to refine and implement oversight tools, trackers, and metrics dashboards.
- Conduct quality control (QC) review of monitoring visit reports and follow-up letters to assess completeness, accuracy, and compliance with monitoring expectations.
- Track visit scheduling, report completion metrics, protocol deviations, and issue resolution to identify trends and risks across CRO, monitor, and site levels.
- Support the development and maintenance of monitoring oversight dashboards and performance metrics (e.g., timeliness, completeness, issue closure, out-of-window visits).
- Assist in implementation of risk-based oversight elements such as key risk indicators (KRIs), key performance indicators (KPIs), and quality tolerance limits (QTLs).
- Collaborate cross-functionally with Clinical Operations, Quality Assurance, and Data Management to ensure consistency in monitoring-related communications, escalation pathways, and issue management.
- Support vendor oversight by reviewing CRO performance reports, contributing to issue escalation, and tracking CAPA progress.
- Participate in inspection readiness activities, document reviews, and process audits to ensure oversight documentation is accurate and current.
- Assist in process improvement initiatives by analyzing oversight data and identifying areas for refinement or standardization.
- Maintain oversight documentation, trackers, and archives to ensure audit and inspection preparedness.
- Support onboarding and training of new COM team members and vendor associates on oversight tools and processes.
- Travel as required (estimated up to 20%).
- Other duties as assigned. Management reserves the right to adjust responsibilities as business needs evolve.
Requirements
- A./B.S. degree in related Life Sciences discipline required
- 7+ years of experience in clinical monitoring or oversight roles.
- Hands-on experience in clinical monitoring, including review of monitoring visit reports and vendor deliverables.
- Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements.
- Experience supporting risk-based monitoring (RBM) and quality metrics programs.
- Demonstrated ability to review, interpret, and analyze monitoring data and reports.
- Familiarity with vendor oversight processes, including KPI tracking and issue management.
- Experience supporting audit or inspection readiness activities.
- Proficiency with oversight tools and systems (CTMS, eTMF, dashboards, Microsoft Office Suite).
- Experience in ophthalmology or retina therapeutic areas preferred.
Benefits
- Equal employment opportunities to all employees and applicants for employment.
- Competitive salary and equitable benefits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical monitoringquality control reviewrisk-based monitoringdata analysisKPI trackingissue managementaudit readinessoversight documentationprocess improvementvendor oversight
Soft skills
collaborationcommunicationproblem-solvingattention to detailorganizational skillstrainingleadership