{"id":3259574,"url":"https://alion.io/job/icon-sr-manager-rbqm-operations","title":"Sr. Manager - RBQM Operations","company":{"id":5677,"name":"ICON","domain":"iconplc.com","url":"https://alion.io/company/icon","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":46,"ghost_share":0,"stale_share":0.978,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Sales","role_family":"Sales","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_regions","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Santiago, Chile","Bogotá, Colombia","Lima, Peru","Brazil","Costa Rica"],"countries":["CL","CO","PE","BR","CR"],"hiring_countries":["AR","BR","CO","MX","AI","AG","AW","BS","BB","BZ","BM","BO","VG","BQ","KY","CL","CR","CW","DM","DO","EC","SV","FK","GF","GD","GP","GT","GY","HT","HN","JM","MQ","MS","NI","PA","PY","PE","PR","KN","LC"],"hiring_countries_total":48,"salary":null,"salary_estimate":{"min_usd":34000,"max_usd":88000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":8012},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"GCP","optional":false},{"name":"ICH Guidelines","optional":false}],"status":"live","first_seen_at":"2026-10-07T00:00:00Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-31T20:50:43Z","board_verified":true,"closed_at":null,"days_open":25,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":25},"description":"Clinical Data Risk Manager - LATAM - RemoteAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.\nAs the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.\nOBJECTIVES:\nThis position reports to a Director of RBQM Operations and is responsible for successfully implementing and coordinating RBQM procedures at the study level, including initial and recurring risk identification, assessment, centralized risk monitoring, and mitigation activities within the RBQM framework.\nACCOUNTABILITIES:\nResponsible for the implementation of RBQM procedures for assigned studiesReviews study protocol and facilitates development of the Study Risk Assessment that defines critical data, critical processes, and meaningful key risk indicators including quality tolerance limits in collaboration with the study team\nDevelops study specific content and leads RBQM training and RBQM kick-off meetings\nAuthors and implements the study specific RBQM plan\nLeads risk assessment meetings, engaging cross-functional study team members to identify Critical-to-Quality (CtQ) risks throughout the trial lifecycle\nPartners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system\nPerforms periodic central monitoring of the aggregate data at the study, region, country, site, and patient levels leveraging available analytics/visualizations in the RBQM system to identify emerging risks and/or issues\nLeads risk review meetings and discussions with study team members to effectively communicate and discuss the findings, facilitates and encourages robust root cause identification and mitigation strategies\nEnsures corrective actions and preventative actions are properly documented, assigned, and implemented by assigned study team members and/or impacted functions\nMonitors the effectiveness of study risk mitigation actions in reducing the risk signals; makes recommendations to adjust as needed\nCreates signal and trending reports for study teams to support their interpretation of RBQM output\nPartners with the Adaptive Monitoring Excellence team for signals requiring review or adjustment to study level plans for targeted source data verification and source data review\nMaintains up-to-date, accurate documentation of RBQM activities\nSupports and participates in internal and external audits and inspections\n\nMaintains high quality, consistency, and compliance with RBQM procedures across studies\nAdjusts RBQM plan appropriately based on both anecdotal feedback and data-driven trends in overall RBQM success measures\nIdentifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes\nActs as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit\nSupports inspections and regulatory interactions as it relates to Takeda’s adoption of RBQM framework\nMay perform line management of other (junior) staff within RBQM Operations\nEDUCATION, EXPERIENCE, KNOWLEDGE, AND SKILLS:\nEducation: Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience\nExperience:\nMinimum of 6 years of experience in the pharmaceutical or CRO industry\nMinimum of 2 years of experience in Risk Based Quality Management\nMinimum of 2 years managerial and supervisory experience\nRobust understanding of the drug development process and clinical trial execution\nKnowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)\nSkills:\nExperience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions\nKnowledge of RBQM IT systems or other data analytic systems\nDemonstrated ability to analyze data, identify patterns and make recommendations for improvement\nDemonstrated ability to effectively lead cross functional team meetings\nExperience forming cross-functional collaborations; strong interpersonal skills\nSupports a culture of continual improvement and innovation; promotes knowledge sharing\nAbility to influence without authority\nThinks creatively; challenges the status quo\nBehavioral Competencies:\nPragmatic and willing to drive and support change\nComfortable with ambiguity\nExcellent teamwork, organizational, interpersonal, and problem-solving skills\nAssertive and collaborative communication style\nAptitude for data analytics; analytical mind\nAttention to detail and a critical thinker\nEmbraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization\nAbility to effectively communicate cross functionally with people of various levels\nEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.\nRewards & Benefits\nICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.\nBenefits may include:\nCompetitive base salary and performance related incentives\nHealth and wellbeing programmes including medical, dental, and vision coverage where applicable\nRetirement and pension plans\nLife assurance and disability coverage\nEmployee assistance programmes and wellbeing resources\nLearning and development opportunities through structured training and career pathways\nBenefits may vary depending on role and location.\nVisit our careers site to read more about the benefits ICON offers.\nInclusion and Accessibility\nICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.\nIf you require reasonable accommodations during the recruitment process, please let us know or submit a request here.\nAre you a current ICON Employee? 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