Sr. Manager/Associate Director, Clinical Monitoring Oversight

Aura Biosciences•Boston, MA

85d•$150,000 - $215,000•Remote

About The Position

Aura Biosciences is seeking a Global Monitoring Manager / Associate Director to join its Clinical Development Operations team. The role leads and oversees clinical monitoring activities across one or more global clinical trials, ensuring compliance with the protocol, Good Clinical Practice, ICH guidelines, applicable regulations, and company SOPs. It provides strategic oversight of CRAs and monitoring vendors, with responsibility for site performance, data quality, patient safety, and inspection readiness across trial regions. The role is the primary escalation point for monitoring-related issues and partners with cross-functional colleagues to deliver trials on time, within budget, and to high quality standards. This is a remote or field-based position requiring regular travel to clinical trial sites, investigator meetings, and company offices. Occasional evening or weekend availability may be needed to support global teams across time zones.

Requirements

Bachelor's degree in life sciences, nursing, pharmacy, or a related field.
7–10 years of clinical research experience, including significant on-site or remote monitoring experience; CRA or Senior CRA background is strongly preferred.
For Associate Director level, typically 3 or more years in a lead CRA, monitoring management, or comparable oversight role.
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 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

Advanced degree.
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, including FDA, EMA, MHRA, or PMDA inspections.
Project management certification (PMP) or clinical research certification (CCRA, ACRP, or SOCRA).

Responsibilities

Collaborate with the Director, Monitoring Strategy and Execution to develop and implement global monitoring strategies, monitoring plans, and risk-based monitoring approaches for assigned trials.
Provide matrix oversight of internal CRAs and/or CRO monitoring teams across countries and regions.
Review and approve site initiation, routine monitoring, and close-out visit reports for quality, completeness, and timeliness.
Review monitoring performance, findings, action items, and follow-up activities to ensure appropriate quality and timeliness.
Oversee source data verification, source data review, and centralized or 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 CRO and monitoring-vendor relationships, ensuring deliverables meet contractual and quality expectations.
Conduct co-monitoring and oversight visits to assess CRA performance and monitoring quality across regions.
Support site and vendor audits and inspections and ensure timely resolution of findings and corrective and preventive actions.
Ensure monitoring activities comply with ICH-GCP, applicable local regulations, and company SOPs and work instructions.
Maintain inspection readiness of the Trial Master File and monitoring documentation.
Track and report key risk indicators and quality metrics, escalating significant risks to study leadership in a timely manner.
Contribute to developing and continuously improving monitoring-related SOPs, tools, and training materials.
Participate in recruitment, onboarding, training, and performance support for CRA staff and/or monitoring vendor teams, where the role includes people-management scope.
Provide therapeutic-area and protocol-specific training to CRAs and site staff.
Promote accountability, quality, and continuous improvement within the monitoring function.
Represent monitoring and site-management perspectives on cross-functional study teams and support study planning and issue resolution.
Prepare and present monitoring status updates, enrollment trends, and site performance metrics to internal stakeholders and leadership.
Contribute monitoring feasibility perspectives to protocol development, informed-consent review, and study start-up.
Support budget and resource forecasting for monitoring activities, including CRA staffing and travel.