Risk Management Specialist

2 weeks ago

Beijing, Beijing, China Parexel Full time

Parexel Job Description

Job Title: Risk Based Study Manager-FSP

About the Role:

The Risk Based Study Manager-FSP will facilitate the initial risk assessment activities including documenting the study-specific RBSM strategy. This role will also facilitate review of periodic risk review output with the Study Team and provide recommendations and guidance on actions. Additionally, the Risk Based Study Manager-FSP will advise the study team on any updates to the monitoring strategy during the study conduct based on the output from the monthly review activities.

Key Responsibilities:

  • Facilitate the initial risk assessment activities including documenting the study-specific RBSM strategy
  • 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
  • Oversees the risk review processes for assigned studies
  • Contributes to the development of standards including tools/templates for RBSM activities
  • 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

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
  • Previous experience with the risk assessment process optional

About Parexel:

Parexel is a leading global biopharmaceutical services company, providing a broad range of solutions, from clinical research to regulatory, consulting, and commercialization services. We are dedicated to helping biopharmaceutical and medical device customers accelerate time-to-market and achieve commercial success.

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