This job is with Parexel, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
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
