Risk and Central Monitoring Manager - Argentina/Mexico - Remote

Who we areWe’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 WorldwideWe 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!What the Risk and Central Monitoring Manager does at Worldwide Clinical TrialsThis role coordinates cross-functional risk management and central monitoring activities for assigned clinical trials in accordance with International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines. The role supports study teams by prioritizing quality across the study and ensuring consistency within programs, therapeutic areas, and/or sponsors.What you will doSupports Risk-Based Quality Management (RBQM) activities within the assigned project teamUnderstands the study budget and protocol content for assigned trialsOversees all Risk-Based Quality Management activities on assigned studiesSupports the development of the Project Management Plan for the assigned program or study and may provide advice on the development of other functional plansDevelops the Central Monitoring Plan for the assigned study and gains Global Project Lead (GPL) and sponsor approvalDelivers training to study teams regarding the RBQM strategy, including study risk assessment, centralized monitoring, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and the overarching monitoring strategyIndependently provides subject matter expertise for the development and maintenance of the study-level monitoring strategy required for the program or trialDrafts and finalizes the initial risk assessment, ensuring cross-functional involvementFacilitates the identification of KRIs and/or QTLs as part of the study monitoring strategy, when applicableOversees the setup of the central monitoring dashboard and central monitoring reviews performed throughout the study, when applicableSupports the GPL in ensuring compliance with cross-functional review of risks throughout the trialPerforms central monitoring activities, when applicable, including review of study- and site-level KRIs and study-level QTLs, review of system outputs, identification of outliers, trends, or signals, and proposal of actions for assessment by the study teamFollows up with study teams as appropriate for action or issue resolutionCompletes User Acceptance Testing (UAT) of RBQM technology, when applicableMaintains the Risk LibraryEnsures inspection readiness for risk assessment and centralized monitoring scopeEnsures adherence to the budget and escalates issues appropriately when neededParticipates as required in bid defense meetings, sponsor meetings, audits, and other third-party meetingsPresents at Risk Manager Forum meetingsSupports the development of departmental strategies and processesActs as a mentor for new or junior team membersPerforms other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.What you will bring to the roleExcellent communication, presentation, and interpersonal skillsExcellent planning and organizational skills with effective time managementGood knowledge of clinical trial financial conceptsStrong analytical skills to analyze complex data and provide insight into risk reports, trends, and data outliersAbility to apply problem-solving and critical-thinking techniques to resolve complex issues and apply a risk-based approach to identify and mitigate potential threats to the successful conduct of a clinical trialAbility to mentorAbility to provide experience and input into process initiatives and development relating to monitoring and site management activitiesComputer literate and numerate, with a willingness to adapt to various computer systems, including proficiency in Microsoft OfficeYour experienceBachelor of Science (BSc), Registered Nurse (RN), or an equivalent combination of knowledge, skills, and experienceAt least five years of experience in clinical research and at lea