Global Monitoring Manager – Clinical Trials Oversight

Aura Biosciences; Boston (MA); Remote; USD 150,000 - 215,000; Full time

Benefits offered by this job

Health insurance (full premium)

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive PTO

Disability and life insurance

Job summary

Aura Biosciences is seeking a Global Monitoring Manager / Associate Director to lead monitoring activities across global trials, ensuring adherence to protocol, GCP, ICH guidelines, and SOPs. You will oversee CRAs and CROs, drive data quality, patient safety, and inspection readiness while collaborating with cross-functional teams in a remote/field-based setting.

This role requires 7–10 years in clinical research, leadership experience, and strong regulatory knowledge.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field (advanced degree a plus).
• 7–10 years of clinical research experience, including significant on-site or remote monitoring experience (CRA/Senior CRA background strongly preferred).
• 3+ years in a lead CRA, monitoring management, or comparable oversight role for AD-level.
• Strong working knowledge of ICH-GCP, FDA, EMA, and other regulatory requirements.
• Experience with RBM methodologies and centralized monitoring tools.
• Proven record of ensuring data quality, patient safety, and inspection readiness across trial sites.

Responsibilities

• Lead monitoring activities across one or more global trials in compliance with protocol, GCP, ICH guidelines, and SOPs.
• Provide oversight of CRAs and CRO monitoring teams across multiple regions.
• Review monitoring reports, findings, and action items for quality and timeliness.
• Oversee SDV/SDR and centralized monitoring to ensure data integrity.
• Identify and resolve site performance issues and protocol deviations.
• Manage site and vendor relationships; support audits and CAPAs.

Skills

Clinical research experience

Leadership / team management

Regulatory compliance knowledge

RBM / risk-based monitoring

Willingness to travel

Education

Bachelor’s degree in life sciences, nursing, pharmacy, or related field

Tools

EDC / eTMF familiarity

CTMS familiarity

Job description

Aura Biosciences is seeking a Global Monitoring Manager / Associate Director to lead monitoring activities across global trials, ensuring adherence to protocol, GCP, ICH guidelines, and SOPs. You will oversee CRAs and CROs, drive data quality, patient safety, and inspection readiness while collaborating with cross-functional teams in a remote/field-based setting.

This role requires 7–10 years in clinical research, leadership experience, and strong regulatory knowledge.