Senior Regional Clinical Trial Management Associate
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Job Description
Clinical trial management associate supporting regional oncology study delivery for BeOne Medicines. Coordinating documentation, vendors, systems, quality, budgets, and country-level trial activities.
Responsibilities:
- Support the Regional Clinical Study Manager in regional study delivery and delegated clinical study components
- Support Clinical Research Associates and/or Study Start-up Specialists in country study delivery
- Apply knowledge of clinical trial operations and support alignment of regional deliverables with overall study goals
- Support regional vendor management and other regional study management activities
- Participate in internal working groups and initiatives
- Serve as a subject matter expert in a specific process and potentially mentor team members
- Support feasibility assessment, study start-up, document generation and review, sample tracking, and participant enrollment
- Support CTMS updates, ISF binder preparation, document collection, ICF customization, and eTMF maintenance
- Support monitoring visit preparation, equipment management, contract activities, regulatory submissions, TMF filing, and SUSAR submissions
- Create and maintain SharePoint folders, distribution lists, and country/site records in eTMF and CTMS
- Support system access and user account management throughout the study lifecycle
- Support local adaptation and review of study-related documents
- Support investigator meetings, TMF creation and quality control, clinical supplies issues, data cleaning, site communications, and routine site questions
- Support public registry information maintenance and Clinical Study Report input
- Support operational risk identification, quality assurance audits and inspections, process improvements, tools, work instructions, and SOPs
- Support vendor selection, regional study budgets, purchase orders, payments follow-up, and accrual activities
Requirements:
- Preferably bachelor's degree, preferably in a scientific or healthcare discipline required; higher degree preferred
- Exceptions might be made for candidates with relevant clinical operations experience
- 2 or more years of experience in clinical research within biotech, pharma or CRO industry
- Knowledge of clinical operations methodologies and understanding of operational aspects of clinical study processes
- MS Office, eTMF, CTMS proficiency
- Limited travel might be required
Benefits:
- Annual bonus plan eligibility for non-commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life insurance
- Paid Time Off
- Wellness benefits
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