Global Clinical Study Manager
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Overview
In this role you lead global oncology clinical studies from feasibility to closeout, ensuring timely delivery within budget and inspection-ready quality. You manage cross-functional teams and external partners, aligning study goals with corporate objectives while driving process improvements. You influence senior stakeholders through regular updates and ensure risk, quality, and regulatory readiness across the study lifecycle. This is a high-impact role at BeOne, enabling impactful cancer programs in a global, collaborative setting.
Retribuzione / Benefits
- remote work
Responsabilità
- Lead global cross-functional study team and external vendors to deliver studies on time and within budget
- Coordinate feasibility, site selection, startup, and activation plans across regions
- Oversee study plans (PM, monitoring, TMF, data monitoring) and ensure timely setup of study systems and training
- Ensure study quality and regulatory readiness, including ICH/GCP compliance and inspection readiness
- Monitor and mitigate risks, implement CAPAs, and communicate risks to senior management
- Drive RBQM end-to-end processes and oversee data cleaning timelines with stakeholders
- Manage budget, resource planning, and contingency plans, including vendor payments
- Collaborate with Global Clinical Supplies to forecast drug delivery to sites
- Prepare and supervise Clinical Study Report production with Medical Writing and CST members
- Lead process improvements, SOPs, and work instructions; support audit and inspection preparations
- Represent the study in internal meetings and lead CST activities and knowledge sharing
Requisiti fondamentali
- 5+ years of progressive experience in clinical research within biotech, pharma, or CRO
- Proven project management experience in global clinical studies, with oncology experience preferred
- Ability to independently lead pivotal oncology studies and manage inspections
- Advanced knowledge of clinical operations methodologies and end-to-end study processes
- Experience with clinical study systems and tools (CTMS, RMBD, data management liaison)
- Strong cross-functional leadership and vendor management skills
- Travel readiness as required by business needs
- collaborative
- strong communication and stakeholder management
- problem solving and decision making
- MS Office
- Clinical Trial Management Systems (CTMS)
- Project Planning Applications
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