Regional Clinical Trial Management Associate
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Job Description
Clinical trial management associate supporting regional oncology study delivery for BeOne. Coordinating startup, documentation, systems, quality, vendors, and country-level trial activities.
Responsibilities:
- Support the Regional Clinical Study Manager in regional study delivery, ensuring delegated clinical study components meet quality, timeline, and budget expectations
- Support feasibility assessment, study start-up, document generation and review, sample tracking, and participant enrollment
- Interpret and implement clinical research regulations and ICH guidelines
- Support regional team meeting setup and logistics
- Collaborate with the Regional Clinical Study Manager, Global Study Management Associate, CRAs, and regional and global stakeholders
- Prepare monitoring visit materials and file documents in the TMF
- Create and maintain regional/country SharePoint folders and study distribution lists
- Set up and maintain countries and sites in eTMF, CTMS, and other systems
- Support system access requests and user account management
- Assist with local adaptation and review of study-related documents
- Support regional/country study start-up and investigator meetings
- Create, maintain, review, and quality-check country/site-level TMF documents
- Resolve regional/country clinical supply issues with stakeholders
- Support data cleaning and follow-up of outstanding information
- Prepare site newsletters and study correspondence
- Assist with routine study questions from clinical trial sites
- Support maintenance of regional/country information in public registries such as CT.gov
- Provide regional/country information for Clinical Study Reports
- Support operational risk identification, quality assurance audits, inspections, process improvements, local/regional tools, work instructions, and SOPs
- Support regional vendor setup and regional study budget and purchase order management
Requirements:
- Bachelor’s Degree in a scientific or healthcare discipline required
- Higher Degree preferred
- Exceptions might be made for candidates with relevant clinical operations experience
- MS Office
- Knowledge of clinical operations methodologies and understanding of operational aspects of clinical study processes
- 1 or more years of experience in clinical research within biotech, pharma or CRO industry
- Limited travel might be required
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