BeOne Medicines
BeOne Medicines
BeOne Medicines स्विट्ज़रलैंड में स्थित एक वैश्विक ऑन्कोलॉजी कंपनी है, जो ऐसे नवीन कैंसर उपचारों की खोज और विकास पर केंद्रित है जिनका उद्देश्य उपचारों की सामर्थ्य और उपलब्धता में सुधार करना है। इसके पोर्टफोलियो में रक्त संबंधी कैंसर और ठोस ट्यूमर के उपचार शामिल हैं। कंपनी की इन-हाउस क्षमताओं और बाहरी सहयोगों के माध्यम से विकसित की जा रही नई उपचार पद्धतियों की पाइपलाइन लगातार विस्तार कर रही है। छह महाद्वीपों में 11,000 से अधिक सहकर्मियों के साथ, BeOne Medicines दुनिया भर के रोगियों के लिए दवाओं की उपलब्धता बढ़ाने के लिए काम कर रही है।

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.

विवरण

  • 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

आवश्यकताएँ

  • 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

लाभ

  • 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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