ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Risk-based Study Management Principal role is responsible for timely and high-quality Risk-based Study Management (RBSM) strategy supporting the client portfolio. This management-level RBSM Lead role is responsible for supporting the study-specific risk assessment process prior to leading the study teams through the periodic risk review process which includes 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. The RBSM Lead demonstrates an exceptional degree of technical and clinical trial expertise while working directly with the cross-functional study team to support the quality oversight of sites, countries, and studies both within the RBSM platforms via the study-specific analytics as well as the parallel process activities.

What you will be doing:

• 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

You possess:

• Bachelor’s degree in relevant discipline (or equivalent degree)
• A minimum of 5+ years of relevant work experience in the Biotech or Pharmaceutical industry, or equivalent comparable background
• A 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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.

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