Senior Manager, Clinical Oversight Monitoring

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November 13

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4D Molecular Therapeutics

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4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations.

51 - 200 employees

📋 Description

• 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.