{"id":4077503,"url":"https://alion.io/job/beone-medicines-global-clinical-study-manager","title":"Global Clinical Study Manager","company":{"id":99686,"name":"BeOne Medicines","domain":"beonemedicines.com","url":"https://alion.io/company/beonemedicines","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":23,"ghost_share":0,"stale_share":0.826,"repost_share":0,"time_to_fill_p50_days":41,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":{"label":"CST","utc_offset_min":-6,"utc_offset_max":-6},"hiring_geo_confidence":"structured","locations":["Italy","France","Spain"],"countries":["IT","FR","ES"],"hiring_countries":["IT"],"hiring_countries_total":1,"salary":{"min":63900,"max":79900,"currency":"EUR","period":"year","gross":null,"usd_annual":89107},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Amazon ECS","optional":false},{"name":"GCP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-11T15:57:35Z","employer_posted_date":"2026-11-11","last_verified_at":"2026-11-11T15:57:35Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.\nGeneral Description:\n Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality\nLeads all aspects of assigned clinical study(ies) \nLeads global cross-functional study team (including oversight of external partners) and acts as point of escalation for resolution of issues within assigned study(ies) \nEnsures alignment of study goals with clinical operations and corporate goals and objectives\nExperience in managing global oncology studies; preferably pivotal studies and inspection management with HA\nEssential Functions of the job:\nCross-Functional Leadership\nLeads the global cross-functional study team effectively, ensures effective decision making, and acts as point of escalation for resolution of study related issues \nLeads external vendors management involved in study delivery \nBuilds trust and relationship with regional subject matter experts and supports the delivery of their local study objectives \nCollaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as required \nRepresents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings \nParticipates and presents at various topics of Clinical Study Management \nParticipates in Clinical Operations Process improvement initiative \nPlanning and Execution\nLeads planning and management of the assigned clinical study(ies) from feasibility through closeout activities \nGenerates, manages, maintains, and communicates high quality study timelines and tracks progress towards these \nEnsures that the clinical studies are operationally feasible along with Global Clinical Program Lead, oversees trial feasibility, trial allocation and site selection process across all regions \nEnsures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs \nProvides oversight to study start up and site activation plans \nEnsures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ...) are created, updated and distributed timely and implemented appropriately \nEnsures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systems \nImplements RBQM end-to-end processes on time within the allocated study (e.g., periodic reviews, centralized monitoring analyses, action items) \nEnsures relevant study specific training is developed and implemented and ensures training records are well documented and filed \nEnsures Trial Master File for study is created, maintained and QC’d on a regular basis as per the study TMF QC plan \nCollaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites \nSupports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor) \nEnsures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members \nQuality and Risk Management\nMonitors study activities to ensure compliance with the study protocol, SOPs, all study plans, ICH/GCP and all other relevant regulations \nRegularly reviews and manages quality-related GCO metrics to be within acceptable limits \nEnsures inspection readiness at any point in time throughout the study life cycle \nWorks with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implemented \nEnsures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implemented \nPrepares team for quality assurance audits and inspections \nCollaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared \nLeads improvements and partners with study team members to enhance the efficiency and the quality of the work performed on assigned studies \nContributes to development, optimization and review of work instructions and SOPs as required \nBudget and Resources\nWorks with the sourcing team to select and manage study vendors, approving invoice payment throughout the study \nManages study budgets, including baseline budget evaluation, change control, study closure budget, presents study budget for senior management engagement \nAdheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts \nIdentifies and manages study team resource needs and establishes contingency plans for key resources. \nMonitors Clinical Study Team resource utilization over the study life cycle Ensures clinical studies at a project level are executed within endorsed time, quality, and cost parameters \nEducation Required:\nBachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred\n*exceptions might be made for candidates with relevant clinical operations experience\nSupervisory Responsibilities:\nProvides performance feedback on team members as required\nComputer Skills:\nMS Office, Project Planning Applications, Clinical Trial Management Systems\nOther Qualifications:\nProven Project Management experience in Global Clinical Studies (Oncology experience preferred) \nAdvanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes \nAble to independently lead global clinical studies (pivotal study management experience required)\n5+ years of progressive experience in clinical research within biotech, pharma or CRO industry \nTravel: Travel might be required as per business need.\nSalary Range Italy: 63,900.00 EUR - 79,900.00 EUR\nSalary Range France: 74,100.00 EUR - 92,600.00 EUR\nSalary Range Spain: 71,400.00 EUR - 89,200.00 EUR\nGlobal Competencies\nWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.\nFosters Teamwork\nProvides and Solicits Honest and Actionable Feedback\nSelf-Awareness\nActs Inclusively\nDemonstrates Initiative\nEntrepreneurial Mindset\nContinuous Learning\nEmbraces Change\nResults-Oriented\nAnalytical Thinking/Data Analysis\nFinancial Excellence\nCommunicates with Clarity\nWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. 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