ABOUT THIS ROLE

• 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

• 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