Clinical Data Risk Management Specialist

4 weeks ago

Darwin, Northern Territory, Australia Pharmiweb Full time
Clinical Data Risk Management Specialist

We are seeking a skilled Clinical Data Risk Management Specialist to join our team at ICON. As a Clinical Data Risk Management Specialist, you will be responsible for the set-up and implementation of Central Monitoring on a portfolio of clinical studies. This is an exciting opportunity to work with a world-leading healthcare intelligence and clinical research organization.

Key Responsibilities:
  • Recognize, exemplify and adhere to ICON's values, which center on Collaboration, Agility, Integrity and Inclusion
  • 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
  • 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 Signals 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 Data Analysis Platform users with system use.
  • Act as mentor for Central Monitoring team members.
  • Travel (approximately 5%) domestic and/or international.
  • Other duties as assigned.
Requirements:
  • 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.
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.

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.

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.

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