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Deschide
BeOne Medicines este o companie globală de oncologie cu sediul în Elveția, axată pe descoperirea și dezvoltarea unor tratamente inovatoare pentru cancer, concepute pentru a îmbunătăți accesibilitatea financiară și accesul la acestea. Portofoliul său acoperă cancerele hematologice și tumorile solide și este susținut de o linie de dezvoltare în expansiune de terapii inovatoare, avansate prin capabilități interne și colaborări externe. Cu peste 11.000 de angajați pe șase continente, BeOne Medicines lucrează pentru a extinde accesul pacienților din întreaga lume la medicamente.
Regional Clinical Study Manager - United States Remote
Lead regional oncology clinical trial delivery for BeOne Medicines across timelines, sites, vendors, budgets, compliance, and operational teams. Oversee study execution from feasibility through closeout while maintaining quality and inspection readiness.
Descriere
- Own regional study delivery to quality, timeline, budget, and inspection-readiness standards
- Serve as regional lead for multiple studies within an indication or program
- Direct regional clinical operations teams and external regional partners
- Act as the escalation contact for regional study challenges
- Coordinate regional deliverables with overarching study objectives
- Create regional tools, work instructions, and standard operating procedures
- Plan and manage regional clinical studies from feasibility through closeout
- Oversee study start-up and recruitment milestones and monitor progress
- Lead trial feasibility assessments, country allocation, and site selection
- Coordinate local updates to global study documents and regulatory or ethics submissions
- Keep regional and country data current in study systems
- Partner with CRAs on study execution and monitoring report reviews
- Oversee creation, maintenance, and quality control of regional and country Trial Master Files
- Contribute to decisions on clinical supplies, drug inventory, labeling, and comparator status
- Manage regional data collection, entry, and query resolution
- Support planning and delivery of Clinical Study Reports
- Monitor adherence to protocols, SOPs, ICH/GCP, and applicable regulations
- Maintain inspection readiness and prepare sites for audits and inspections
- Lead quality enhancements and communicate effective practices
- Select and oversee regional vendors
- Manage regional clinical study budgets
- Oversee investigator fees, site payments, and patient travel reimbursements
- Plan regional resource requirements and monitor utilization
- Provide performance feedback and mentor junior colleagues
Cerințe
- Bachelor’s degree in a scientific or healthcare discipline is required
- An advanced degree is preferred
- At least six years of progressive clinical research experience in biotechnology, pharmaceuticals, or a CRO
- Demonstrated clinical research experience, including team leadership in clinical functions
- CRA experience is preferred
- Proficiency with Microsoft Office
- Proficiency with project planning applications
- Relevant clinical operations experience may support an exception to the degree requirement
- Travel may be required based on business needs
Beneficii
- Eligibility for an annual bonus plan in non-commercial roles
- Eligibility for an incentive compensation plan in commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) plan
- FSA/HSA
- Life insurance
- Paid time off
- Wellness benefits
- Reasonable accommodation throughout the application process
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