Risk and Monitoring Associate Manager

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Join us!

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.

This is a REMOTE role open to candidates based in Remote. You will collaborate with global teams across multiple time zones.

• 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.

• 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…