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Regional Clinical Trial Management Associate
Support regional clinical study delivery, trial documentation, study systems, and budgets at BeOne Medicines. The company develops cancer medicines and therapies.
Tavsif
- Assist the Regional Clinical Study Manager with regional study delivery and delegated study activities.
- Help Clinical Research Associates and Study Start-up Specialists deliver studies within their countries.
- Support trial feasibility, start-up, document preparation and review, sample tracking, and participant enrollment.
- Update CTMS records; prepare ISF binders; collect and customize documents, including ICFs; and maintain the eTMF.
- Apply relevant regulations and ICH guidelines.
- Coordinate regional and country team meetings, including agendas and minutes.
- Maintain SharePoint folders, distribution lists, eTMF, CTMS, and other study systems.
- Help manage system access requests and user accounts.
- Assist with study start-up and investigator meetings, and with TMF creation, review, and quality checks.
- Help address regional or country clinical supply issues and support data cleaning.
- Draft site newsletters and clinical trial correspondence.
- Maintain public registry information and contribute to Clinical Study Reports.
- Assist with operational risk identification, audits, inspections, tools, work instructions, and SOPs.
- Help set up vendors and manage regional study budgets, purchase orders, payment follow-up, and accruals.
Talablar
- At least one year of clinical research experience in biotechnology, pharmaceuticals, or a CRO.
- Knowledge of clinical operations methods and the operational aspects of clinical study processes.
- Experience with MS Office, eTMF, and CTMS.
- A bachelor’s degree, preferably in a scientific or healthcare field, is preferred.
- Some travel may be required.
- Exceptions may be considered for candidates with relevant clinical operations experience.
Imtiyozlar
- Eligible for an annual bonus plan in non-commercial roles.
- Eligible for incentive compensation in commercial roles.
- Discretionary equity awards.
- Optional participation in the Employee Stock Purchase Plan.
- Medical insurance.
- Dental insurance.
- Vision coverage.
- 401(k) plan.
- FSA/HSA accounts.
- Life insurance.
- Paid time off.
- Wellness benefits.
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