Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJob DescriptionGlobal Study Lead – This position is a fully client-embedded role, dedicated to a leading bio-pharma company.Role Purpose:This GSL is a single accountable person and a Clinical Operations representative. Will drive operational strategy, planning and leading the study and being aligned with the asset strategy. The GSL and GSM work s a leadership-operational duo. Key Responsibilities:1. Overall Study LeadershipOwn the day-to-day management of the global clinical studyLead cross-functional study teams (clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, etc.)Ensure alignment between global strategy and regional executionDrive study timelines, milestones, and deliverables 2. Study Planning and ExecutionDevelop and maintain:study timelinesoperational plansrisk management plansenrollment strategies Oversee country start-up, site activation, recruitment, monitoring, and closeoutEnsure protocol execution is consistent globally 3. Vendor and CRO OversightManage external vendors and CRO partnersTrack performance metrics and service qualityResolve operational issues and escalationsEnsure vendors meet contractual obligations and timelines4. Budget and Resource ManagementMonitor study budgets and forecastsTrack study spend against planIdentify resource gaps and operational risksSupport financial governance and change management 5. Risk and Issue ManagementIdentify study risks earlyLead mitigation and contingency planningHandle escalations related to:recruitment delaysprotocol deviationsdata quality issuessupply shortagesinspection readiness 6. Regulatory and Quality ComplianceEnsure study conduct follows:ICH-GCPlocal regulationsSOPsprotocol requirements Support inspection readiness and audit activitiesOversee CAPAs when needed 7. Cross-Functional CommunicationServe as the central operational contact for the studyCommunicate updates to:senior leadershipstudy teamsregional teamssponsors/partnersLead governance meetings and study reviews 8. Data and Study OversightMonitor enrollment, data cleaning, query resolution, and database lock readinessReview KPIs and operational metricsEnsure timely delivery of quality data 9. Strategic Decision-MakingMake operational decisions that impact study deliveryBalance quality, speed, cost, and patient safetyRecommend process improvements and efficienciesEducation Requirements:- Bachelor’s degree: life sciences or related discipline; The role will require a good understanding of complex clinical development and regulatory processes.Role Related Experience:At least 6+ years of relevant study management experience on a global level.In-depth experience in clinical research: study management, monitoring, data managementPrevious in-depth Oncology experienceMust have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset –Must have proven experience from study feasibility to CSRMust have at least Ph II and PIII experience – PI & PIV is an assetMust have cross-functional leadership proven experience, able to drive internal and external meetingAble to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systemsStrong experience in clinical budget managementStrong experience with vendor management including CROExposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...), being involved in studies pivotal for drug file registration is an assetFluent in English, to the level they can negotiate and discuss (adapt message) related to complex topics with any Clinical team member (Local country representative, Statistician, Data Manager, laboratory, central laboratory, Scientific writer, safety representative, study Phycician and any type of vendors as well as able to present clear status to upper management if required.Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectivesStrong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPsGood project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)