Sr. Manager/Assocaite Director, Clinical Monitoring Oversight

Aura Biosciences•Boston, MA

7d•$150,000 - $215,000•Remote

About The Position

Aura Biosciences is looking to expand its Clinical Development Operations (CDO) team with this newly created position of Global Monitoring Manager / Associate Director (GMM/AD). The Global Monitoring Manager / Associate Director (GMM/AD) leads and oversees clinical monitoring activities across one or more global clinical trials, ensuring studies are conducted in compliance with the protocol, Good Clinical Practice (GCP), ICH guidelines, applicable regulations, and company Standard Operating Procedures (SOPs). This role is responsible for the strategic oversight of Clinical Research Associates (CRAs) and/or monitoring vendors (CROs), driving site performance, data quality, patient safety, and inspection readiness across all regions in which the trial(s) are conducted. The GMM/AD serves as the primary point of escalation for monitoring-related issues and partners closely with Clinical Trial Managers, Data Management, Biostatistics, Regulatory, Quality Assurance, and Medical Monitors to ensure trials are delivered on time, within budget, and to the highest quality standards.

Requirements

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.
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.

Nice To Haves

Experience across multiple therapeutic areas and trial phases (Phase I–IV) in drug, combination product and/or device clinical trials.
Direct people-management experience with distributed, global teams.
Familiarity with electronic data capture (EDC), electronic Trial Master File (eTMF), and clinical trial management systems (CTMS).
Experience supporting regulatory inspections (FDA, EMA, MHRA, PMDA, etc.).
Project management certification (PMP) or clinical research certification (CCRA, ACRP, SOCRA), a plus.

Responsibilities

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.
Partner with Clinical Trial Managers and Site Management teams on site selection, feasibility, and activation timelines.
Manage relationships with contract research organizations (CROs) and monitoring vendors, ensuring deliverables meet contractual and quality expectations.
Conduct co-monitoring and oversight visits to assess CRA performance and ensure consistent monitoring quality across regions.
Support site and vendor audits and inspections; ensure timely resolution of findings and CAPAs (Corrective and Preventive Actions).
Ensure all monitoring activities comply with ICH-GCP, applicable local regulations, and company SOPs/work instructions.
Maintain inspection readiness of the Trial Master File (TMF) and monitoring documentation at all times.
Track and report key risk indicators (KRIs) and quality metrics; escalate significant risks to study leadership in a timely manner.
Contribute to the development and continuous improvement of monitoring-related SOPs, tools, and training materials.
Participate in recruitment, onboarding, training, and support management performance of CRA staff and/or monitoring vendor teams (for people-manager scope).
Provide therapeutic area and protocol-specific training to CRAs and site staff.
Foster a culture of accountability, quality, and continuous improvement within the monitoring function.
Serve as a key member of the cross-functional study team, representing monitoring/site management perspectives in study planning and issue resolution.
Prepare and present monitoring status updates, enrollment trends, and site performance metrics to internal stakeholders and leadership.
Contribute to protocol development, informed consent review, and study start-up activities from a monitoring feasibility perspective.
Support budget and resource forecasting for monitoring activities, including CRA staffing and travel.