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Senior Global Clinical Study Manager
BeOne Medicines. Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading global clinical studies, ensuring compliance with ICH/GCP regulations, and managing project timelines and budgets. Proven ability to mentor team members and collaborate with cross-functional teams to achieve study goals.
Highest-signal resume keywords
Project ManagementGlobal Clinical StudiesClinical Trial Management SystemsOncology ExperienceClinical Operations Methodologies
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 Study ProcessesStudy Timelines ManagementData CleaningQuality Metrics ManagementRisk Mitigation Plans
Soft Skills
LeadershipCollaborationMentoring
Tools & Technologies
MS OfficeProject Planning Applications
Industry Keywords
BiotechPharmaCROSOPsInspection Readiness
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality
- Lead all aspects of assigned clinical studies
- Lead global cross-functional study teams, including oversight of external partners
- Act as point of escalation for resolution of study-related issues
- Ensure alignment of study goals with clinical operations and corporate goals and objectives
- Contribute to development of global tools and standards; lead development of work instructions and SOPs
- Lead global cross-functional study teams and external vendor management
- Collaborate with regional subject matter experts and organizational stakeholders
- Provide regular study progress updates to senior management
- Lead planning and management of clinical studies from feasibility through closeout
- Manage study timelines, feasibility, trial allocation, site selection, startup, site activation, study plans, systems, training, TMF, data cleaning, supplies, and Clinical Study Reports
- Monitor compliance with protocols, SOPs, study plans, ICH/GCP, and applicable regulations
- Manage quality metrics, inspection readiness, audits, inspections, issues, CAPAs, risks, and mitigation plans
- Select and manage study vendors and approve invoice payments
- Manage study budgets, accruals, forecasts, and resource needs
- Mentor junior team members
Requirements
What you’ll need- 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 global clinical studies
- 7+ or more years of progressive experience in clinical research within biotech, pharma or CRO industry
- MS Office, Project Planning Applications, Clinical Trial Management Systems
- Bachelor’s Degree in a scientific or healthcare discipline required
- Travel might be required as per business need
Benefits
Comp & perks- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life insurance
- Paid Time Off
- Wellness program