Hiring: Sr. Manager/Associate Director, Clinical Monitoring Oversight Company: Aura Biosciences Location: Boston, MA Job Posted Time: 2026-09-10 11:45:06 Employment Type: Contract / Remote Target Skills & Keywords : GCP, Project Management, Quality Assurance, Risk Management, Segment, Stakeholder Management, Vendor Management About the job Experience: •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. Required Skills: •Aura Biosciences is the world's preeminent ocular oncology company. We are leveraging a novel targeted oncology platform to develop a potential new standard of care with a focus on ocular oncology. •Collaborating with the Director, Monitoring Strategy and Execution, they will help develop and implement the global monitoring strategy, monitoring plans, and risk-based monitoring (RBM) approach for assigned trial(s). •Provide matrix oversight of internal CRAs and/or CRO monitoring teams across multiple countries and regions. •Review and approve monitoring visit reports (site initiation, routine monitoring, and close-out visits) for quality, completeness, and timeliness. •Review monitoring performance, visit reports, findings, action items, and follow-up activities to ensure appropriate quality and timeliness. •Oversee source data verification (SDV), source data review (SDR), and centralized/remote monitoring activities to ensure data integrity. •Identify, escalate, and drive resolution of site performance issues, protocol deviations, and data quality trends. •Site & Vendor Management Qualifications: •Bachelor's degree in life sciences, nursing, pharmacy, or a related field (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. •Demonstrated 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. •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. •Direct people-management experience with distributed, global teams. •Operational familiarity with electronic data capture (EDC), electronic Trial Master File (eTMF), and clinical trial management systems (CTMS). •Project management certification (PMP) or clinical research certification (CCRA, ACRP, SOCRA), a plus. Compensation: •$150,000 - $215,000 / year •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!