Senior Clinical Trial Manager

EPFL

EPFL, the Swiss Federal Institute of Technology in Lausanne, is one of the most dynamic university campuses in Europe and ranks among the top 20 universities worldwide. The EPFL employs more than 6,500 people supporting the three main missions of the institution: education, research and innovation. The EPFL campus offers an exceptional working environment at the heart of a community of more than 17,000 people, including over 12,500 students and 4,000 researchers from more than 120 different countries.Short DescriptionThe Laboratory for Intelligent Global Health and Humanitarian Technologies (LiGHT) at EPFL is seeking an experiencedSenior Clinical Trial Manager (CTM)to lead and oversee multi-country clinical trials evaluating AI-enabled clinical decision support tools in low- and middle-income countries (LMICs), with a focus on Sub-Saharan Africa and India.This is a unique opportunity to contribute to mission-driven, high-impact research advancing safe, equitable, and high-quality healthcare in underserved settings. The ideal candidate combines operational excellence with empathy, analytical thinking, and the ability to work effectively in diverse, international teams.MissionThe Laboratory for Intelligent Global Health and Humanitarian Response Technologies (LiGHT)https://www.light-laboratory.org/is an impact-driven research group creating novel AI tools specifically adapted to limited-resource and volatile global health settings and bringing them to scaled, locally owned implementation.It is based at the Swiss Institute of Technology (EPFL) - In the top 10 computer science institutions globally, EPFL is a deeply international hub for technical excellence in AI.Our mission is to develop safe, scalable, and context-aware digital health tools. We work with international NGOs such as WHO, MSF, ICRC, and national ministries of health to design, create, validate and deploy trustworthy AI in real-world healthcare systems"”especially in settings where clinical resources are limited and stakes are high.Main duties and responsibilitiesClinical Trial OperationsLead end-to-end implementation of global clinical trials from feasibility through close-outOversee site identification, initiation, monitoring, and close-out, ensuring compliance with ICH-GCP and local regulationsCoordinate regulatory and ethics submissions, approvals, and communications in LMIC contextsAct as the primary operational contact for CROs, vendors, and research sitesMonitor study progress, timelines, and budgets, identifying and resolving challenges proactivelyLead investigator meetings, site trainings, and monitoring visits, ensuring effective collaboration and adherence to protocolsQuality & ComplianceEnsure all trial activities meet ICH-GCP, local regulatory, and ethical standardsConduct and oversee on-site, remote, and centralized monitoring to maintain data integrity and participant safetyIdentify and mitigate risks and operational issues, maintaining comprehensive documentationSupport audit and inspection readiness, contributing to continuous improvement initiatives(Preferred) Contribute to or support the maintenance and documentation of the Quality Management System (QMS) to strengthen quality oversightTeam Leadership & Capacity StrengtheningSupervise and mentor Clinical Operations team members and CRAs, offering guidance and supportStrengthen local research capacity through training and ongoing knowledge exchangeCollaborate with data management, biostatistics, and regulatory affairs teams to ensure cohesive project deliveryPartnerships & Cross-Cultural CollaborationBuild and maintain strong partnerships with clinical sites, investigators, and local research institutionsWork effectively in multicultural, international, and multidisciplinary environmentsDemonstrate cultural sensitivity, inclusion, and adaptability in all interactionsSupport the ethical and context-appropriate integration of AI-enabled tools into real-world healthcare settingsDocumentation & ReportingMaintain accurate and complete Trial Master File (eTMF) and operational recordsPrepare study progress reports, monitoring summaries, and final reportsContribute to scientific publications, presentations, and regulatory submissions as requiredProfileAdvanced degree in life sciences, medicine, public health, or a related field4+ years of hands-on clinical trial management experience, ideally in multi-country interventional studies within LMICsProven expertise in clinical monitoring, data verification, and quality assuranceComprehensive understanding of ICH-GCP and international regulatory requirementsExperience with EDC systems, (e)TMF, and Quality Management Systems (QMS) preferredFamiliarity with AI, digital health, or medical device studies is an advantageDemonstrated ability to manage cross-functional teams and collaborate effectively across geographies and culturesFluency in English required; French proficiency strongly preferred (for collaboration in West Africa)Willingness t...