【About the role】
We have an exciting opportunity for motivated individuals to join our clinical operations team working to bring cell therapies to the clinical stage. The successful candidate will be expected to be a good team player, work with enthusiasm to execute assignments properly.
【Position Title】 Senior Clinical Trial Manager/ Clinical Assistant Program Manager (title may be adjusted based on experience)
【Location】 Taipei, Taiwan
【Reports to】 Senior Clinical Operations Director
【Job Type】 Full-time
【Education /Background】
• Bachelor’s degree or above in healthcare and life science related field
• 5+ years of Clinical Research experience that includes a minimum 3 years relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least 1 years as a Project Manager, CRA Manager, Clinical Trial Manager or equivalent job role.
• 2+ years of experience working at clinical sites in Taiwan or with clinical sites via trial management or monitoring role, or a combination of bothOncology experience, with cell therapy experience strongly desired.
• Robust understanding of ICH/GCP and regulatory requirements
• Specific Project Management training, or Clinical Research training and/or certification is a plus
【Responsibilities include, but are not limited to】
• Clinical trial planning and management in all aspects: study document development/review (study-specific plans, manual, and guidelines, etc.,), clinical trial operation, study budget planning, and study metrics.
• Ensures clinical trials are conducted in compliance with the study protocol, health authority regulations, and ICH/GCP guidelines: planning quality assurance initiatives for the clinical trials, participating the audit activities and coordinates resolution of audit findings of vendors and CROs (including CAPA documentation and resolution); ensures audit-ready condition of clinical trial documentation with vendors and CROs.
• Manages the study submission to health authority and IRB/ECs in coordination with project team, vendors and CROs.
• Provides study-specific training and leadership to clinical research staff, including vendors, CROs, sites and/or other contract personnel if required.
• Take the lead with study team to select external vendors and is responsible for the management/oversight of external vendors including: the development of vendor specifications; review vendor reports, budgets, and metrics.
• Take the lead with study team to manage the study budget: Ensures the study budget execution aligns with study plan; reviews and approves study invoices against approved budget. Coordinates review of revisions and/or change orders with vendors, if necessary
• Prepares and presents project debriefings to Head of Clinical Operations/CMO
• Uses operational expertise to optimize study operation design and works with the study team to strategize on clinical trial conduction.
• Works with the CRO to select and approve sites and manages start-up processes toward activating sites; develops relationships with investigators and site staff.
• Works cross-functionally with Clinical Development, Data Management, CRO, vendors, and clinical investigators/site staff to proactively manage the conduction of the clinical trials.
• May require occasional domestic and/ or international business travel.
• May require occasional evening working hours for attending international teleconferences
• Other duties and assignments as required by the project. (May be assigned to the project team in the joint project with other departments (e.g. quality assurance, business development, operations)
