The RBSM Central Risk plays a critical role contributing to the embedding, growth and continuous improvement of the clinical study risk management process. The RBSM Central Risk is responsible for supporting the study teams with initial risk assessment process, 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, and leading the monthly study risk review process.

The RBSM demonstrates a strong degree of technical and clinical trial expertise while working directly with the study team to support the quality oversight of sites, countries and studies both within the RBSM platforms as well as the parallel process activities.

What you will be doing:

• Supports the RBSM Lead with collating observations and preparing the review to support the monthly risk review activities.
• Facilitates review of findings with the study team
• Supports study teams through the central risk-based management processes
• Assist the RBSM Lead with completing the RACT activities across protocols
• Keen comprehension of the assessment and management of risks, including the ability to analyze aggregated data and interpret risk indicators to evaluate site performance and data quality
• Manage the risk review and trigger management process for studies
• Able to resolve conflicts, execute clear communication with both internal customers and vendors
• Supports study-specific set up on RBSM platforms, including but not limited to testing and validation
• Performs other duties as assigned

You are:

• Clinical Development experience in site and/or study management
• Experience using data driven methods to analyze and solve business situations and problems
• Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Ability to interpret communicate complex data insights into understandable actionable messages
• Ability to organize tasks, time and priorities; ability to multi-task
• Ability to communicate effectively and appropriately with internal external stakeholders, locally and globally
• Ability to train and mentor individuals
• Must have experience with data visualization and data analytics tools

EDUCATION AND EXPERIENCE:

• S. (or equivalent degree) and 3-5 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background
• Prefer minimum of at least 1 year experience of working in centralized monitoring/RBSM