Senior Manager/Associate Director, Clinical Monitoring Oversight

Aura Biosciences

Clinical monitoring leader overseeing CRA teams, CROs, and risk-based monitoring for Aura Biosciences’ global ocular cancer trials. Ensuring compliance, data quality, patient safety, and inspection readiness.

Posted 8/18/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $150,000 - $215,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical trial monitoring, ensuring compliance with GCP, ICH guidelines, and regulatory requirements while managing CRA teams and CRO relationships. Proven ability to implement risk-based monitoring strategies and maintain inspection readiness across multiple therapeutic areas and trial phases.

Highest-signal resume keywords

Clinical Research ExperienceRisk-Based Monitoring (RBM)ICH-GCP KnowledgeLeadership in CRA ManagementProject Management Certification (PMP)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MonitoringSource Data VerificationData Quality AssuranceProtocol DevelopmentMonitoring Plan DevelopmentSite Performance ManagementRegulatory ComplianceCentralized Monitoring ToolsTherapeutic Area ExpertiseInspection Readiness

Soft Skills

LeadershipCommunicationNegotiationCritical Thinking

Tools & Technologies

Electronic Data Capture (EDC)Electronic Trial Master File (eTMF)Clinical Trial Management Systems (CTMS)

Certifications & Qualifications

Clinical Research Certification (CCRA)Project Management Certification (PMP)Society of Clinical Research Associates (SOCRA)

Industry Keywords

Good Clinical Practice (GCP)International Council for Harmonisation (ICH)FDA RegulationsEMA RegulationsClinical Trial Phases (I-IV)CRO ManagementSite SelectionMonitoring StrategiesAudit SupportCAPA Resolution

Tech Stack

Tools & technologies

Google Cloud PlatformPMP

About the role

Key responsibilities & impact

Lead and oversee clinical monitoring activities across one or more global clinical trials
Ensure studies comply with protocols, Good Clinical Practice (GCP), ICH guidelines, applicable regulations, and company SOPs
Develop and implement global monitoring strategies, monitoring plans, and risk-based monitoring approaches
Provide matrix oversight of internal CRAs and/or CRO monitoring teams across multiple countries and regions
Review and approve site initiation, routine monitoring, and close-out visit reports
Review monitoring performance, findings, action items, and follow-up activities
Oversee source data verification, source data review, and centralized/remote monitoring activities
Identify, escalate, and resolve site performance issues, protocol deviations, and data quality trends
Partner on site selection, feasibility, and activation timelines
Manage CRO and monitoring vendor relationships and deliverables
Conduct co-monitoring and oversight visits to assess CRA performance
Support site and vendor audits and inspections; ensure timely resolution of findings and CAPAs
Maintain inspection readiness of the Trial Master File and monitoring documentation
Track and report key risk indicators and quality metrics
Contribute to monitoring-related SOPs, tools, and training materials
Participate in recruitment, onboarding, training, and performance management of CRA staff and/or vendor teams
Provide therapeutic-area and protocol-specific training to CRAs and site staff
Represent monitoring/site management perspectives on cross-functional study teams
Prepare and present monitoring updates, enrollment trends, and site performance metrics
Contribute to protocol development, informed consent review, and study start-up activities
Support monitoring budget and resource forecasting, including CRA staffing and travel

Requirements

What you’ll need

Bachelor's degree in life sciences, nursing, pharmacy, or a related field required; advanced degree a plus
Minimum 7–10 years of clinical research experience, including significant on-site or remote monitoring experience
CRA/Senior CRA background strongly preferred
Typically, 3+ years in a lead CRA, monitoring management, or comparable oversight role for AD-level
Experience managing or overseeing CRA teams and/or CRO monitoring vendors on global or multi-regional trials
Strong working knowledge of ICH-GCP, FDA, EMA, and other applicable global regulatory requirements
Experience with risk-based monitoring (RBM) methodologies and centralized monitoring tools
Proven record of ensuring data quality, patient safety, and inspection readiness across clinical trial sites
Excellent leadership, communication, negotiation, and critical thinking skills
Willingness and ability to travel domestically and internationally as required
Experience across multiple therapeutic areas and trial phases (Phase I–IV) in drug, combination product and/or device clinical trials preferred
Direct people-management experience with distributed, global teams preferred
Familiarity with electronic data capture (EDC), electronic Trial Master File (eTMF), and clinical trial management systems (CTMS) preferred
Experience supporting regulatory inspections (FDA, EMA, MHRA, PMDA, etc.) preferred
Project management certification (PMP) or clinical research certification (CCRA, ACRP, SOCRA) a plus

Benefits

Comp & perks

Health insurance with FULL premium coverage
401K with company match
Employee Stock Purchase Program (ESPP)
Competitive paid time off (PTO)
Company-paid short & long-term disability insurance
Company-paid life insurance
Remote or field-based work arrangement
Occasional evening or weekend availability to support global teams across time zones