Risk and Central Monitoring Associate Manager
Worldwide Clinical Trials
Summary
Help drive quality and oversight across clinical trials by supporting risk management and central monitoring activities that are critical to study success. In this role, you'll work with cross-functional teams to identify, assess, and monitor study risks while helping ensure trials are conducted in accordance with ICH GCP guidelines.
Job description
Make an Impact as a Risk and Central Monitoring Associate Manager at Worldwide
Help drive quality and oversight across clinical trials by supporting risk management and central monitoring activities that are critical to study success. In this role, you'll work with cross-functional teams to identify, assess, and monitor study risks while helping ensure trials are conducted in accordance with ICH GCP guidelines.
You'll play an important role in advancing Risk-Based Quality Management (RBQM) strategies, supporting study teams with risk assessments, centralized monitoring activities, and data-driven insights that help maintain quality throughout the clinical trial lifecycle.
Working closely with internal stakeholders and sponsors, you'll contribute to consistent, inspection-ready processes while helping teams focus on what matters most: delivering high-quality clinical research that supports better outcomes for patients.
Where You'll Work
This is a REMOTE role open to candidates based in Remote. You will collaborate with global teams across multiple time zones.
What You'll Do
- Lead and oversee Risk-Based Quality Management (RBQM) activities for assigned clinical studies.
- Develop and maintain Central Monitoring Plans, ensuring appropriate approvals and alignment with study strategies.
- Support the creation and ongoing review of study risk assessments, partnering with cross-functional teams to identify and evaluate risks.
- Facilitate the identification, tracking, and monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).
- Perform centralized monitoring reviews to identify trends, outliers, signals, and potential risks, recommending actions to study teams.
- Maintain central monitoring dashboards and support ongoing monitoring activities throughout the study lifecycle.
- Deliver training and guidance to study teams on RBQM strategies, monitoring approaches, and risk management processes.
- Contribute to inspection readiness activities, budget awareness, sponsor interactions, audits, and other project-related meetings.
What You'll Bring
- BSc, RN, or an equivalent combination of education, skills, and experience.
- At least 4 years of clinical research experience, including a minimum of 3 years of experience with Risk-Based Monitoring (RBM) and associated ICH/regulatory guidance.
- Prior experience working as a Central Monitor or within a Central Monitoring function.
- Strong understanding of RBQM principles, study risk assessments, centralized monitoring, KRIs, and QTLs.
- Demonstrated ability to analyze complex data, identify trends and risks, and apply critical thinking to problem-solving and issue resolution.
- Experience collaborating across functions and working effectively within global project teams.
- Strong communication, presentation, planning, and organizational skills.
- Proficiency in English and strong proficiency with Microsoft Office and clinical technology systems.
Requirements
- BSc, RN, or an equivalent combination of education, skills, and experience.
- At least 4 years of clinical research experience.
- Minimum of 3 years of experience with Risk-Based Monitoring (RBM) and associated ICH/regulatory guidance.
- Prior experience working as a Central Monitor or within a Central Monitoring function.
- Strong understanding of RBQM principles, study risk assessments, centralized monitoring, KRIs, and QTLs.
- Demonstrated ability to analyze complex data, identify trends and risks, and apply critical thinking to problem-solving and issue resolution.
- Experience collaborating across functions and working effectively within global project teams.
- Strong communication, presentation, planning, and organizational skills.
- Proficiency in English and strong proficiency with Microsoft Office and clinical technology systems.
Benefits
- Competitive benefits package
Company overview
Worldwide Clinical Trials is a leading global contract research organization (CRO) that provides comprehensive clinical development services to pharmaceutical, biotechnology, and medical device companies. Founded with a mission to accelerate the development of innovative therapies, the company offers end-to-end solutions spanning from early-phase research through late-stage clinical trials and regulatory submissions. With expertise across multiple therapeutic areas including oncology, central nervous system disorders, cardiovascular diseases, and rare conditions, Worldwide Clinical Trials leverages its scientific knowledge and operational excellence to design and execute complex clinical studies. The organization maintains a global footprint with operations across North America, Europe, and Asia-Pacific regions, enabling it to conduct multinational trials efficiently. Known for its patient-centric approach and commitment to quality, Worldwide Clinical Trials plays a crucial role in advancing medical research and bringing new treatments to patients worldwide.