Senior Clinical Research Associate
Remote, United States · remote
Salary not posted
Who we are 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. Why Worldwide 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! Make an Impact as a Risk and Central Monitoring Associate Manager at Worldwide Play a key role in advancing clinical research quality by supporting risk management and central monitoring activities across global clinical trials. In this role, you'll help study teams identify, assess and mitigate risks, ensuring trials are conducted in line with ICH GCP guidelines while maintaining a strong focus on quality and patient outcomes. Working cross-functionally with project teams, you'll contribute to the development and execution of Risk-Based Quality Management (RBQM) strategies, support central monitoring activities, and provide valuable insights from data trends, risk indicators and study performance metrics. Your expertise will help drive consistency across studies, programmes and sponsors while supporting inspection readiness and successful study delivery. Where You'll Work This is a remoterole open to candidates based in UK and Europe. You will collaborate with global teams across multiple time zones. What You'll Do Lead and oversee RBQM activities for assigned clinical trials, ensuring alignment with study objectives and regulatory expectations Develop and maintain Central Monitoring Plans, securing required approvals and supporting effective study oversight Coordinate cross-functional risk assessments and facilitate the identification of key study risks, KRIs and QTLs where applicable Support study teams through training and guidance on RBQM strategies, central monitoring approaches and risk management processes Perform central monitoring reviews, analysing trends, outliers and risk signals to identify potential issues and recommend actions Contribute to the development and maintenance of study-level monitoring strategies that support quality-focused trial execution Ensure inspection readiness by maintaining high-quality risk management and central monitoring documentation Support technology-related activities, including user acceptance testing of RBQM tools and central monitoring solutions Participate in sponsor meetings, bid defence activities, audits and other stakeholder engagements as required What You'll Bring BSc, Registered Nurse qualification, 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 in Risk-Based Monitoring and relevant ICH/regulatory guidance Previous experience working as a Central Monitor or within a central monitoring function Strong understanding of RBQM principles, risk assessment methodologies, KRIs, QTLs and study monitoring strategies Ability to analyse complex data, identify trends and outliers, and translate findings into meaningful risk insights and recommendations Demonstrated critical thinking and problem-solving sk
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Remote, United States · remote
Salary not posted
Florida, US · onsite
Salary not posted
Mason, OH; Minnetonka, MN · hybrid
$106k–$125k