„BeOne Medicines“ yra Šveicarijoje įsikūrusi pasaulinė onkologijos bendrovė, daugiausia dėmesio skirianti novatoriškų vėžio gydymo būdų paieškai ir kūrimui, siekiant pagerinti jų įperkamumą ir prieinamumą. Jos produktų portfelis apima hematologinius vėžinius susirgimus ir solidinius navikus, o jį papildo plečiamas naujų gydymo priemonių kūrimo planas, įgyvendinamas pasitelkiant vidines kompetencijas ir išorės partnerystes. Daugiau nei 11 000 darbuotojų šešiuose žemynuose turinti „BeOne Medicines“ siekia didinti vaistų prieinamumą pacientams visame pasaulyje.
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.
Jungtinės Valstijos136 400 $ – 181 400 $ / metai
NuotolinisVisas etatasVyresnysis specialistasPrivaloma Kalba: anglųKlinikiniai tyrimaiAprašymas
- 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.
Reikalavimai
- 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.
Privalumai
- 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.