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Clinical Data Risk Analyst

  1. Sofia, Warsaw, Bucharest, Johannesburg, Bratislava
JR120928
  1. Clinical Data Management
  2. ICON Full Service & Corporate Support
  3. Hybrid: Office/Remote

About the role

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.

The responsibilities of the Clinical Data Risk Analyst include, but are not limited to:

- 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

EXPERIENCE & SKILLS

  • 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

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

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, 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.

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