Risk and Central Monitoring Associate Manager
New
J
JobgetherClinical research
Fully remote work arrangement for eligible candidates based in BrazilFull-TimeManager
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- Proficiency in English, with the ability to communicate effectively in an international working environment.
- Experience
- At least four years of experience in clinical research, including a minimum of three years working with Risk-Based Monitoring (RBM) and associated ICH guidelines or regulatory guidance.
- Required Skills
- Microsoft Office
Requirements
- Hold a bachelor's degree in a relevant field, a registered nursing qualification (RN), or an equivalent combination of education, skills, and professional experience.
- Have at least four years of experience in clinical research.
- Have a minimum of three years working with Risk-Based Monitoring (RBM) and associated ICH guidelines or regulatory guidance.
- Have previous experience as a Central Monitor or within a Central Monitoring function.
- Demonstrate understanding of RBQM, study risk assessments, centralized monitoring, KRIs, and QTLs.
- Have knowledge of clinical trial quality oversight and risk-based approaches throughout the study lifecycle.
- Be able to analyze complex clinical data, identify trends and anomalies, assess risks, and recommend actions.
- Demonstrate critical-thinking, problem-solving, planning, organizational, and time-management skills.
- Have experience collaborating across functional teams and contributing to global clinical research projects.
- Communicate and present monitoring findings and risk-management strategies effectively to diverse stakeholders.
- Be proficient in English.
- Have strong proficiency in Microsoft Office applications and familiarity with clinical research technology systems.
- Be able to work independently in a remote setting and collaborate across teams and time zones.
Responsibilities
- Lead and oversee RBQM activities for assigned clinical studies.
- Develop, maintain, and coordinate approvals for Central Monitoring Plans.
- Support study risk assessments with cross-functional teams.
- Identify, track, evaluate, and monitor KRIs and QTLs.
- Conduct centralized monitoring reviews to identify trends, outliers, emerging signals, and risks.
- Recommend follow-up actions and risk mitigation strategies based on monitoring findings.
- Maintain central monitoring dashboards and support monitoring throughout the clinical trial lifecycle.
- Provide training and practical guidance to study teams on RBQM and centralized monitoring.
- Support inspection readiness through documentation quality and monitoring records.
- Collaborate with sponsors, global project teams, and internal stakeholders on study oversight and regulatory compliance.
View Full Description & ApplyYou'll be redirected to the employer's site
