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BeOne Medicines
BeOne Medicines
Asistență medicalăBiotehnologieProduse farmaceutice
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.
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Regional Clinical Study Manager - United States Remote

Lead regional oncology clinical trial delivery for BeOne Medicines, coordinating operations, vendors, timelines, budgets, quality, and regulatory execution across assigned countries.

USStatele Unite ale Americii
118.600 $ – 158.600 $ / an
RemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Own regional study delivery while maintaining inspection-ready quality, approved timelines, and budget performance
  • Lead the regional clinical operations team and manage external regional partners
  • Serve as the escalation contact for regional study issues
  • Keep regional deliverables aligned with overall study objectives
  • Chair regional operations meetings and represent the regional study team in internal and cross-functional forums
  • Plan and manage assigned clinical studies from feasibility through regional closeout
  • Create, manage, and maintain regional start-up and recruitment timelines
  • Direct trial feasibility, country allocation, and site selection with relevant stakeholders
  • Contribute regional perspectives to global study plans
  • Coordinate local adaptations of global study documents and support timely regulatory and EC/IRB submissions
  • Ensure study submissions are completed in assigned countries with study start-up and regulatory teams
  • Maintain regional and country data in study systems and related tools
  • Partner with CRAs on site execution and review and approve monitoring reports
  • Ensure country- and site-level Trial Master Files are established, maintained, and quality-checked
  • Advise on regional drug inventories, local labeling, comparator approvals, and reimbursement status
  • Oversee regional trial data collection, data entry, and query resolution
  • Support Clinical Study Report planning and delivery
  • Resolve escalated site issues and monitor adherence to protocols, SOPs, ICH/GCP, and applicable regulations
  • Maintain regional inspection readiness and implement solutions to study issues
  • Prepare sites for audits and inspections and lead responses to findings
  • Distribute lessons learned and effective practices across teams
  • Lead process improvements and contribute to work instructions and SOPs
  • Select and manage regional study vendors in partnership with sourcing
  • Control regional study budgets
  • Coordinate investigator fees, site payments, and patient travel reimbursements
  • Identify regional staffing needs and contingency plans
  • Track regional resource utilization
  • Provide performance feedback and mentor junior team members when needed

Cerințe

  • At least four 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
  • A bachelor's degree in a scientific or healthcare field is required; an advanced degree is preferred
  • Relevant clinical operations experience may be considered in place of the stated degree requirement
  • Proficiency with Microsoft Office
  • Proficiency with project planning applications
  • Working knowledge of clinical study delivery, clinical operations, study start-up, recruitment, feasibility, country allocation, site selection, regulatory submissions, TMF management, data collection, query resolution, ICH/GCP, SOPs, and applicable regulations
  • Willingness to travel as business needs require

Beneficii

  • Eligibility for an annual bonus plan in non-commercial roles
  • Eligibility for an incentive compensation plan in commercial roles
  • Discretionary equity award opportunities
  • Employee Stock Purchase Plan
  • Medical insurance coverage
  • Dental insurance coverage
  • Vision insurance coverage
  • 401(k) retirement plan
  • Flexible Spending Account and Health Savings Account options
  • Life insurance
  • Paid time off
  • Wellness benefits
  • Reasonable accommodations for applicants with disabilities

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