Global Clinical Study Manager

General Description:

• Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality
• Leads all aspects of assigned clinical study(ies)
• Leads global cross-functional study team(including oversight of external partners)and acts as point of escalation for resolution of issues within assigned study(ies)
• Ensures alignment of study goals with clinical operationsand corporategoals andobjectives
• Experience in managing global oncology studies; preferably pivotal studies and inspection management with HA

Essential Functions of the job:

Cross-Functional Leadership

• Leads the global cross-functional study team effectively, ensures effective decision making, and acts as point of escalation for resolution of study related issues
• Leads external vendorsmanagementinvolvedin study delivery
• Buildstrust and relationship with regional subject matter experts and supports the delivery of their local study objectives
• Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management asrequired
• Representsthe study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings
• Participates and presents atvarious topicsof Clinical Study Management
• Participates in Clinical Operations Process improvement initiative

Planning andExecution

• Leads planning and management of the assigned clinical study(ies) from feasibilitythrough closeout activities
• Generates, manages,maintains, and communicates high quality study timelines and tracks progress towards these
• Ensures that the clinical studies are operationallyfeasiblealong with Global Clinical Program Lead, oversees trial feasibility, trialallocationand site selection process across all regions
• Ensurestimelyavailability of high-quality study documents to allow study submission to regulatory authoritiesand ECs/IRBs
• Provides oversight to study start up and site activation plans
• Ensuresstudy plans (egproject management plan,monitoringplan, Trial Master File plan, data monitoring plan, ...) are created,updatedand distributedtimelyand implemented appropriately
• Ensures 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
• ImplementsRBQM end-to-end processes on time within theallocatedstudy (e.g., periodic reviews, centralized monitoring analyses, action items)
• Ensures relevant study specific training is developed and implementedand ensures training records are well documented and filed
• Ensures Trial Master File for study is created,maintainedandQCon a regular basisas per the study TMF QC plan
• Collaborates closely with Global Clinical Supplies to forecast study drug andtimelydelivery of supplies to sites
• Supports 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)
• Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writingand relevant CST members

Qualityand Risk Management

• Monitors study activities to ensure compliance withthe study protocol,SOPs,all study plans,ICH/GCP and all other relevant regulations
• Regularly reviews and manages quality-related GCO metrics to be within acceptable limits
• Ensures inspection readiness at any point in time throughout the study life cycle
• Works with cross-functional study team toidentify, interpret, and evaluate issues on the study and ensurescorrective and preventative actionsare implemented
• Ensuressenior management and other key stakeholders are informed of risks and challenges andensuresrisk mitigation plans are put in place and implemented
• Prepares team for quality assurance auditsand inspections
• Collaborates withCST members and othercolleagues to ensure cross-team, site learnings, and best practices are shared
• Leads improvementsand partners with study team membersto enhance the efficiency and the quality of the work performed on assignedstudies
• Contributes to development, optimizationand review of work instructions and SOPs asrequired

Budget and Resources

• Works with the sourcing team to select and manage study vendors, approving invoice payment throughout the study
• Managesstudybudgets, including baseline budget evaluation, change control, study closure budget,presents studybudgetforsenior managementengagement
• Adheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts
• Identifiesand managesstudy teamresource needs andestablishescontingency plans for key resources.
• MonitorsClinical Study Teamresourceutilizationover the study life cycleEnsures clinical studies at a project level are executed withinendorsedtime, quality, and cost parameters

Education Required:

BachelorDegree in a scientific or healthcare discipline required*, Higher Degree preferred

*exceptionsmight be made for candidates with relevant clinical operations experience

Supervisory Responsibilities:

Provides performance feedback on team members as required

Computer Skills:

MS Office, Project Planning Applications, Clinical Trial Management Systems

Other Qualifications:

• Proven Project Management experience in Global Clinical Studies (Oncology experience preferred)
• Advanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes
• Able to independently lead globalclinicalstudies(pivotal study management experience required)
• 5+ years of progressive experience in clinical research within biotech,pharmaor CRO industry

Travel: Travel might be required as per business need.

Global Competencies

When 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.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.