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BeOne Medicines
BeOne Medicines
BiotechnologyHealthcarePharmaceuticals
BeOne Medicines is a Switzerland-domiciled global oncology company focused on discovering and developing innovative cancer treatments designed to improve affordability and access. Its portfolio covers hematologic cancers and solid tumors, supported by an expanding pipeline of novel therapeutics advanced through in-house capabilities and external collaborations. With more than 11,000 colleagues across six continents, BeOne Medicines is working to broaden access to medicines for patients worldwide.
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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.

USUnited States
$118,600 – $158,600 / year
RemoteFull-timeMiddleSeniorEnglish RequiredClinical Research
Google Cloud Platform

Description

  • 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

Requirements

  • 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

Benefits

  • 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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