Sr. Manager/Associate Director, Clinical Monitoring Oversight
Aura Biosciences
August 18, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Global Monitoring Manager / Associate Director (GMM/AD)
Responsibilities:
- Develop and implement global monitoring strategy, monitoring plans, and risk-based monitoring (RBM) for assigned trials.
- Provide matrix oversight of internal CRAs and/or CRO monitoring teams across countries/regions.
- Review/approve monitoring visit reports (initiation, routine, close-out) for quality, completeness, and timeliness.
- Oversee SDV/SDR and centralized/remote monitoring to ensure data integrity.
- Identify, escalate, and drive resolution of site performance issues, protocol deviations, and data quality trends.
- Partner on site selection/feasibility and activation timelines.
- Manage CROs/monitoring vendors to ensure contractual/quality deliverables.
- Conduct co-monitoring/oversight visits; support audits/inspections and timely CAPA resolution.
- Ensure monitoring activities comply with ICH-GCP, regulations, and SOPs; maintain TMF/monitoring documentation inspection readiness.
- Track/report KRIs and quality metrics; contribute to monitoring SOPs/tools/training.
- Recruit/onboard/train and provide therapeutic area/protocol training; foster continuous improvement.
- Provide monitoring status updates, enrollment/site performance metrics; support protocol/study start-up and monitoring budgeting/resource forecasting.
Required Qualifications:
- Bachelor’s degree (life sciences/nursing/pharmacy or related; advanced degree a plus).
- 7–10 years clinical research experience, including significant monitoring (CRA/Senior CRA preferred); 3+ years in lead/management/oversight (AD-level).
- Experience overseeing CRA teams and/or CRO monitoring on global/multi-regional trials.
- Knowledge of ICH-GCP and FDA/EMA and other global regulatory requirements.
- RBM and centralized monitoring tools experience.
- Proven data quality, patient safety, and inspection readiness.
- Leadership, communication, negotiation, critical thinking; domestic/international travel.
Preferred Qualifications:
- Phase I–IV experience across drug/combination product/device.
- People-management experience with distributed global teams.
- EDC, eTMF, and CTMS familiarity.
- Inspection support experience; PMP/CCRA/ACRP/SOCRA.
Benefits:
- Health insurance with full premium coverage.
- 401(k) with company match; ESPP.
- Competitive paid time off (PTO).
- Company-paid short/long-term disability and life insurance.
Responsibilities:
- Develop and implement global monitoring strategy, monitoring plans, and risk-based monitoring (RBM) for assigned trials.
- Provide matrix oversight of internal CRAs and/or CRO monitoring teams across countries/regions.
- Review/approve monitoring visit reports (initiation, routine, close-out) for quality, completeness, and timeliness.
- Oversee SDV/SDR and centralized/remote monitoring to ensure data integrity.
- Identify, escalate, and drive resolution of site performance issues, protocol deviations, and data quality trends.
- Partner on site selection/feasibility and activation timelines.
- Manage CROs/monitoring vendors to ensure contractual/quality deliverables.
- Conduct co-monitoring/oversight visits; support audits/inspections and timely CAPA resolution.
- Ensure monitoring activities comply with ICH-GCP, regulations, and SOPs; maintain TMF/monitoring documentation inspection readiness.
- Track/report KRIs and quality metrics; contribute to monitoring SOPs/tools/training.
- Recruit/onboard/train and provide therapeutic area/protocol training; foster continuous improvement.
- Provide monitoring status updates, enrollment/site performance metrics; support protocol/study start-up and monitoring budgeting/resource forecasting.
Required Qualifications:
- Bachelor’s degree (life sciences/nursing/pharmacy or related; advanced degree a plus).
- 7–10 years clinical research experience, including significant monitoring (CRA/Senior CRA preferred); 3+ years in lead/management/oversight (AD-level).
- Experience overseeing CRA teams and/or CRO monitoring on global/multi-regional trials.
- Knowledge of ICH-GCP and FDA/EMA and other global regulatory requirements.
- RBM and centralized monitoring tools experience.
- Proven data quality, patient safety, and inspection readiness.
- Leadership, communication, negotiation, critical thinking; domestic/international travel.
Preferred Qualifications:
- Phase I–IV experience across drug/combination product/device.
- People-management experience with distributed global teams.
- EDC, eTMF, and CTMS familiarity.
- Inspection support experience; PMP/CCRA/ACRP/SOCRA.
Benefits:
- Health insurance with full premium coverage.
- 401(k) with company match; ESPP.
- Competitive paid time off (PTO).
- Company-paid short/long-term disability and life insurance.