Clinical Data Risk Analyst

Clinical Data Risk Analyst - Bulgaria, Sofia

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Clinical Data Risk Analyst to join our diverse and dynamic team.

: - Help on the study risk management process, including risk assessment, and appropriate risk control and monitoring approach - Lead the kick-off meeting dedicated to RBM with the CTT- Manage the activities for the set-up of RBM on a study- Propose the KRI and lead the discussion to finalize the KRI design- Help the RBM Clinical Data Scientist define the analytical strategy (frequency of review, focus of analyses, by site, by country…) in conjunction with the Study Team (CTT)- Review and pre-mitigate the data findings and signals with the RBM Clinical Data Scientist- Make decision and provide recommendation for certainly Signals; coordinate review for those uncertainty signals by the study team.- Review analysis to create site-specific signals to be used by Site Monitors (CRA)- Support CRA in the use of RBM approach at site level- Formalize an action plan for/jointly with the study team to be implemented as adapted RBM (frequency of visit, % sdv etc.…)- Closely collaborate with RBM Clinical Data Scientist and study team - Conduct RBM closure activities, including archive, share lessons & learned- Follow RBM processes defined for the global and local team- Provide mentoring to new RBM Clinical Data Risk Analyst- Support study team and monitoring teams for the use of Clue Points platform based on the RBM results of the study (in collaboration with RBM Clinical Data Scientist )- Design and architect proper methods, technique and evaluation criteria for complex project- Contribute to development of company concepts and principles in creative and effective ways

- Solid understanding of RBM/RBQM - Some experience with analysis of data (for example in ICONIK or other visualization platform) - With Risk based thinking and strong risk identification, monitoring and mitigation ability - Cluepoints experience is a strong added value - With at least 3-5 years CRA/DM background - Strong communication, presentation skills - Have the leadership for all RBM activities

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply