Execute and oversee centralized monitoring activities across clinical trials using a risk-based quality management (RBQM) framework
Perform ongoing centralized monitoring reviews using clinical, operational, and quality data sources
Identify emerging study-level and site-level risks through Key Risk Indicators (KRIs)
Support the evaluation of trends, data anomalies, and protocol deviations
Document and report signals, findings, and recommendations within designated systems
Collaborate with Clinical Monitoring to support alignment of monitoring approaches with ICH-GCP E6 (R2/R3) and internal SOPs
Support oversight of centralized monitoring vendors, tools, or platforms
Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials

Requirements

Bachelor’s degree in life sciences, health sciences, or related disciplines
5 years of clinical research experience
Centralized monitoring, RBQM, or clinical data review experience
Strong understanding of clinical trial processes
Solid understanding and demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory requirements.
Highly advanced knowledge of ICH-GCP E6 (R2/R3) and risk-based requirements.
Experience with clinical trial systems such as EDC, eTMF, IRT, and CTMS.
Strong interpersonal skills with advanced oral/written communication and presentation skills.
Proficiency in Microsoft Office tools.

Benefits

Health insurance plans for employees (and their families) including medical, dental, vision and basic life insurance
401k match
20 days of PTO
10 paid holidays
Winter company shutdown
Discretionary annual target bonus
Stock options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

centralized monitoringrisk-based quality managementclinical data reviewGood Clinical PracticesICH Guidelinesregulatory requirementsclinical trial processesdata anomaly evaluationprotocol deviation analysisKey Risk Indicators

Soft Skills

interpersonal skillsoral communicationwritten communicationpresentation skills