Clinical Data Analyst

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
 

This role can be based remotely or office based in Bulgaria, South Africa, Romania, Hungary, Latvia, Lithuania or Czech Republic

The Role:

We are looking for a Clinical Data Analyst to join the Clinical Risk Management team at ICON. Candidates for this exciting opportunity should have strong knowledge of Clinical Research, Risk Based Monitoring, and Central Monitoring in the Pharma or CRO industry.

As Clinical Risk Management functional lead, the Clinical Data Analyst is responsible for set-up and implementation of Central Monitoring on a portfolio of clinical studies.

The Role:

• Recognize, exemplify and adhere to ICON's values, which center on Accountability & Delivery, Collaboration, Partnership and Integrity

• Recognize the importance  of and create a  culture  of process  improvement with a focus  on streamlining  our processes  adding  value  to our business  and meeting client needs

• Creation and ownership of the Central Monitoring Plan

• Provide input to study risk assessment and propose appropriate and tailored risk indicators for central analysis, in line with holistic data monitoring model

• Support set-up and testing of data analysis platform ICONik

• Review clinical study data and make independent decisions to identify potential site performance and site organization issues

• Manage operational risk log for Clinical Risk Management activities

• Train and support the project teams about interpretation of Central Monitoring outputs and relevant decision making for study conduct

• Support preparation, conduct and follow-up of the Quality Risk Review Meetings for effective communication with the cross functional project team to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issues

• Oversee Clinical Risk Management project budget, scope of work, forecasting

• Communicate effectively with the project team, CRAs, Project Managers, Clinical Trial Managers, DM Staff, Medical staff, Scientific Council to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issue

• Support cross-functional and external ICONik users with system use

• Act as mentor for Central Monitoring team members

• Travel (approximately 5%) domestic and/or international

• Other duties as assigned

To be successful in the role, you will ideally have:

• University/Bachelor’s Degree in medicine, science or equivalent degree/experience

• Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management and Central Monitoring

• 3-4 years’ experience in Clinical Research (CRA or DM background), or relevant skillset

• Knowledge of database technologies and processes

• Fluent in written and spoken English

• Excellent communication and interpersonal skills, attention to detail

• Demonstrate ownership and accountability for achieving results

• Ability to work within a team environment and manage competing priorities in a changeable environment

• Proven Functional Lead skills and the ability to work independently and apply critical thinking skills to resolve study related issues

• Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license and passport

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.