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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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Locurile de muncă ale companiei

Global Clinical Study Manager – Remote, United States

Lead global clinical study delivery for BeOne Medicines, coordinating cross-functional teams, vendors, timelines, budgets, quality, and regulatory readiness. This role oversees oncology-focused clinical operations from feasibility through study closeout.

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

Descriere

  • Own global study delivery against approved timelines, budgets, and inspection-readiness standards
  • Direct all activities for assigned clinical studies
  • Lead global cross-functional study teams, oversee external partners, and escalate study issues when needed
  • Align study objectives with clinical operations priorities and corporate goals
  • Manage external vendors and work with regional subject matter experts
  • Provide senior management with regular updates on study progress
  • Represent the study team in internal forums and chair Clinical Study Team meetings
  • Direct study planning and execution from feasibility through closeout
  • Develop, maintain, and communicate comprehensive study timelines
  • Oversee regional trial feasibility, allocation, and site selection
  • Ensure study documents are available on time for regulatory and ethics submissions
  • Manage study start-up activities and site activation plans
  • Ensure study plans, systems, and tools are established, implemented, and maintained
  • Apply risk-based quality management and centralized monitoring analyses
  • Create study-specific training, deliver it as needed, and maintain training records
  • Create, maintain, and quality-check the Trial Master File
  • Forecast study drug demand and coordinate timely supply deliveries to sites
  • Support data-cleaning milestones with Data Management and other stakeholders
  • Plan and deliver the Clinical Study Report with Medical Writing and study team contributors
  • Monitor adherence to protocols, SOPs, study plans, ICH/GCP, and applicable regulations
  • Review quality metrics and sustain inspection readiness
  • Identify study issues and ensure corrective and preventive actions are completed
  • Report risks and challenges to senior management and implement mitigation strategies
  • Prepare study teams for quality assurance audits and inspections
  • Share lessons learned and effective practices across teams and sites
  • Lead process improvements and contribute to work instructions and SOPs
  • Select and oversee study vendors and approve invoice payments
  • Manage study budgets, change control, closeout budgets, accruals, and forecasts
  • Assess study staffing needs and monitor resource utilization
  • Keep studies within approved time, quality, and cost parameters

Cerințe

  • Demonstrated project management experience across global clinical studies
  • Oncology experience is preferred
  • Advanced knowledge of clinical operations methods and practices
  • Thorough understanding of end-to-end clinical study processes
  • Capability to independently lead global clinical studies
  • At least six years of progressively responsible clinical research experience in biotech, pharmaceutical, or CRO organizations
  • Proficiency with Microsoft Office
  • Experience using project planning software
  • Experience with Clinical Trial Management Systems
  • Bachelor’s degree in a scientific or healthcare field required; an advanced degree is preferred
  • Willingness to travel when business needs require

Beneficii

  • Eligibility for an annual bonus plan in non-commercial roles
  • Eligibility for an incentive compensation plan in commercial roles
  • Eligibility for discretionary equity awards
  • Access to a voluntary Employee Stock Purchase Plan
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k) plan
  • FSA/HSA options
  • Life insurance
  • Paid time off
  • Wellness benefits
  • Reasonable accommodation during the job application process

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