Job Purpose
The Risk-based Study Management Principal role is responsible for timely and high-quality Risk-based Study Management (RBSM) strategy supporting the sponsor portfolio. This management-level RBSM Lead role is responsible for supporting the study-specific risk assessment process prior to leading the study teams through the periodic risk review process which includes ongoing assessment of Key Risk Indicators (KRIs) to identify issues and emerging risks in clinical trial variables (trends/outliers/poor performing sites) through the review of aggregate data. The RBSM Lead demonstrates an exceptional degree of technical and clinical trial expertise while working directly with the cross-functional study team to support the quality oversight of sites, countries, and studies both within the RBSM platforms via the study-specific analytics as well as the parallel process activities.
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
