Central Risk Based Monitor - Home-Based (US or Canada)

As a Central Monitor you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Risk-based Study Management (RBSM) Central Monitor plays a critical role contributing to the embedding, growth, and continuous improvement of the clinical study risk management process. The RBSM Central Risk Manager is responsible for supporting the RBSM Lead with the 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 Central Monitor 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 data and 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 centralized RBSM processes
• Assist the RBSM Lead with completing the Risk Assessment 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 action management process for studies as part of monthly risk review activities
• Implements the risk-based SDV strategy defined by the RBSM Lead in collaboration with the study Primary Clinical Data Manager (PCDM)
• Contributes to the creation and management of the RBSM supporting documentation
• Able to resolve conflicts, execute clear communication with both internal customers and vendors
• Supports study-specific set-up of RBSM platforms, including, but not limited to, testing and validation
• Performs other duties as assigned

You are:

• Bachelor's degree in relevant discipline (or equivalent degree)
• Typically 3-5 years of relevant work experience in the Biotech or Pharmaceutical industry, or equivalent comparable background
• Minimum of at least 1 year experience working in centralized monitoring and/or risk-based study management
• 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
• Ability to interpret and communicate complex data insights into understandable and actionable messages
• 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
• Ability to train and mentor individuals
• Must have experience with data visualization and data analytics tools

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.