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Senior Global Clinical Study Manager
BeOne Medicines. Accountable for global study delivery within agreed timelines, budget, and inspection-readiness quality .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing global clinical studies, ensuring compliance with regulatory standards, and leading cross-functional teams. Proficient in project management, clinical operations methodologies, and vendor management within the biotech or pharma industry.
Highest-signal resume keywords
Global Clinical Study ManagementProject Management ExperienceClinical Trial Management Systems (CTMS)Regulatory ComplianceOncology Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Operations MethodologiesStudy PlanningRisk-Based Quality ManagementData CleaningBudget ManagementStudy Progress ReportingVendor ManagementStudy-Specific Training DevelopmentTrial Master File ManagementFeasibility Assessment
Soft Skills
LeadershipProblem-SolvingCollaborationCommunicationEscalation Management
Tools & Technologies
MS OfficeProject Planning ApplicationsClinical Trial Management Systems (CTMS)
Industry Keywords
BiotechPharmaCROICH/GCPClinical ResearchInspection ReadinessSOPsStudy BudgetsClinical Study ReportOncology
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Accountable for global study delivery within agreed timelines, budget, and inspection-readiness quality
- Lead all aspects of assigned clinical studies
- Lead global cross-functional study teams and oversee external partners
- Act as escalation point for study-related issue resolution
- Align study goals with clinical operations and corporate objectives
- Develop global tools and standards, work instructions, and SOPs
- Support onboarding and high-quality execution of external partner projects
- Lead vendor management and collaborate with regional subject matter experts
- Provide study progress updates to senior management
- Lead study planning and management from feasibility through closeout
- Manage study timelines, feasibility, site selection, startup, activation, and study plans
- Ensure regulatory and ethics committee submission documents are available
- Implement risk-based quality management processes and maintain study systems
- Develop study-specific training and maintain training records
- Create, maintain, and quality-control the Trial Master File
- Forecast study drug supplies and coordinate delivery to sites
- Support data cleaning timelines and Clinical Study Report planning
- Monitor compliance with protocols, SOPs, ICH/GCP, study plans, and regulations
- Manage quality metrics, inspection readiness, audits, inspections, risks, and corrective/preventive actions
- Select and manage vendors and approve invoice payments
- Manage study budgets, forecasts, accruals, resources, and contingency plans
- Participate in process-improvement initiatives and share best practices
Requirements
What you’ll need- Bachelor’s degree in a scientific or healthcare discipline required, with exceptions possible for candidates with relevant clinical operations experience
- 8 or more years of progressive experience in clinical research within biotech, pharma, or CRO industry
- Proven project management experience in global clinical studies
- Advanced knowledge of clinical operations methodologies
- In-depth understanding of all aspects of clinical study processes
- Ability to independently lead global clinical studies
- MS Office proficiency
- Project planning applications proficiency
- Clinical Trial Management Systems (CTMS) proficiency
- Ability to travel domestically and internationally, up to 20%
- Oncology experience preferred
- Higher degree preferred
Benefits
Comp & perks- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Voluntary Employee Stock Purchase Plan participation
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life insurance
- Paid Time Off
- Wellness benefits
- Reasonable accommodation for individuals with disabilities