Senior Manager/Associate Director, Clinical Monitoring Oversight

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $150k - $215k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Aura Biosciences

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Aura Biosciences is a biotechnology company focused on developing innovative cancer treatments. It is currently enrolling patients in the global Phase 3 CoMpass trial to evaluate the safety and efficacy of belzupacap sarotalocan (bel-sar) for treating small choroidal melanoma. The company utilizes a novel Virus-Like Drug Conjugates (VDCs) platform to target various solid tumors, with an emphasis on ocular and urologic oncology. Aura Biosciences aims to create a new standard of care in cancer treatment by offering early intervention options that preserve patient vision and improve long-term outcomes. The company is actively involved in research and clinical trials to address cancers like choroidal melanoma and non-muscle-invasive bladder cancer.

📋 Description

• 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

• 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

• 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