Risk Based Study Manager-FSP
Australia, Remote Job ID R0000029300 Category Clinical TrialsAbout this Role
Responsibilities：
- Facilitates the initial risk assessment activities including documenting the study-specific RBSM strategy
- Facilitates review of periodic risk review output with the Study Team and provides recommendations and guidance on actions
- Advises the study team on any updates to the monitoring strategy during the study conduct based on the output from the monthly review activities
- Oversees the risk review processes for assigned studies
- Contributes to the development of standards including tools/templates for RBSM activities (can function as a workstream owner)
- Ensures the training of RBSM Central Risk Managers (at all levels) and Study Team members on processes, platforms, tools, and templates
- Provides technical expertise to set-up and test study-level Risk Assessment Module and Central Monitoring Modules design in the designated RBSM platform
- Provides input on initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines, and deliverables
- Contributes to periodic portfolio level risk review with functional area representatives to identify enterprise-level trends, corrective actions, etc.
- Able to resolve conflicts, influence and communicate cross-functionally with key stakeholders and customers.
- Functional/line management of RBSM Central Risk Managers (at all levels)
- Performs other duties as assigned
Requirement：
- Bachelor’s degree in relevant discipline (or equivalent degree)
- Prefer minimum of 5+ years of relevant work experience in the Biotech or Pharmaceutical industry, or equivalent comparable background
- Prefer minimum of 1-2 years’ experience working in centralized monitoring and/or risk-based study management
- Technical expertise and business experience in supporting clinical trial database development, data management, site monitoring, etc.
- Thorough understanding of the processes associated with clinical study management and data management
- Project management skills and technical capabilities
- Works independently, receives instruction primarily on unusual situations
- Ability to organize tasks, time, and priorities; ability to multi-task
- Effective and appropriate verbal and written communication with internal and external stakeholders, locally and globally
- Must have experience with data visualization and data analytics tools
- Previous experience with the risk assessment process optional
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