Regulatory Study Manager

7 days ago

Shanghai, Shanghai, China Parexel Full time

Parexel is seeking a highly skilled Regulatory Study Manager to join our team. This role will be responsible for facilitating the initial risk assessment activities, including documenting the study-specific strategy.

About the Role
  • Facilitate review of periodic risk review output with the Study Team and provide 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.
  • Oversee the risk review processes for assigned studies.
  • Contribute to the development of standards, including tools/templates for RBSM activities (can function as a workstream owner).
  • Ensure the training of RBSM Central Risk Managers (at all levels) and Study Team members on processes, platforms, tools, and templates.
  • Provide technical expertise to set-up and test study-level Risk Assessment Module and Central Monitoring Modules design in the designated RBSM platform.
  • Provide input on initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines, and deliverables.
  • Contribute 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).
Requirements
  • 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.
What We Offer

We offer a competitive salary of $120,000 per year, plus additional benefits such as health insurance, retirement plan, and paid time off.

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