The RBSM Central Risk plays a critical role contributing to the embedding, growth and continuous improvement of the clinical study risk management process. The RBSM Central Risk r is responsible for supporting the study teams with initial 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 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:
KEY RESPONSIBILITIES:
- Supports the RBSM Lead with collating 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 central risk-based management processes
- Assist the RBSM Lead with completing the RACT 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 the risk review and trigger management process for studies
- Able to resolve conflicts, execute clear communication with both internal customers and vendors
- Supports study-specific set up on RBSM platforms, including but not limited to testing and validation
- Performs other duties as assigned
TECHNICAL AND COMMUNICATIVE SKILLS:
- 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.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
- Ability to interpret & communicate complex data insights into understandable & actionable messages
- Ability to organize tasks, time and priorities; ability to multi-task
- Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
- Ability to train and mentor individuals
- Must have experience with data visualization and data analytics tools
You are:
- B. S. (or equivalent degree) and 3-5 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background
- Prefer minimum of at least 1 year experience of working in centralized monitoring/RBSM
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.
