Icon plc

Clinical Data Analyst

Job description

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 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 knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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, 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

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