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.
Senior Global Clinical Study Manager
Lead global clinical trials for BeOne Medicines, a cancer medicines developer. Oversee study delivery, cross-functional teams, vendors, budgets, quality, and regulatory readiness.
Statele Unite ale Americii136.400 $ – 181.400 $ / an
RemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinicăDescriere
- Own global study delivery to agreed timelines and budgets while maintaining inspection-ready quality.
- Oversee all aspects of assigned clinical studies.
- Lead global cross-functional study teams and oversee external partners.
- Resolve study-related issues as the escalation point.
- Align study goals with clinical operations and corporate objectives.
- Help develop global tools and standards, and lead work instruction and SOP development.
- Manage external vendors and global cross-functional study teams.
- Work with regional subject matter experts and organizational stakeholders.
- Keep senior management informed with regular study progress updates.
- Plan and manage clinical studies from feasibility through closeout.
- Manage timelines, feasibility, trial allocation, site selection and startup, site activation, study plans and systems, training, TMF, data cleaning, supplies, and Clinical Study Reports.
- Monitor adherence to protocols, SOPs, study plans, ICH/GCP, and applicable regulations.
- Oversee quality metrics, inspection readiness, audits, inspections, issues, CAPAs, risks, and mitigation plans.
- Select and manage study vendors, and approve invoice payments.
- Oversee study budgets, accruals, forecasts, and resource needs.
- Mentor junior team members.
Cerințe
- Demonstrated project management experience in global clinical studies; oncology experience is preferred.
- Advanced knowledge of clinical operations methodologies.
- In-depth understanding of clinical study processes.
- Ability to independently lead global clinical studies.
- At least seven years of progressive clinical research experience in biotech, pharmaceuticals, or a CRO.
- Experience with Microsoft Office, project planning applications, and clinical trial management systems.
- Bachelor’s degree in a scientific or healthcare discipline.
- Willingness to travel as business needs require.
Beneficii
- Eligibility for an annual bonus plan for non-commercial roles.
- Eligibility for an incentive compensation plan for commercial roles.
- Discretionary equity awards.
- Employee stock purchase plan.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k) plan.
- Flexible spending and health savings accounts.
- Life insurance.
- Paid time off.
- Wellness program.