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Senior Clinical Data Risk Analyst

2 months ago

Hobart, Australia Pharmiweb Full time
Senior Clinical Data Risk Analyst

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.

Job Description Summary

The Senior Clinical Data Risk Analyst will be responsible for effectively managing the activities of RBQM (Risk Based Quality Management) across specific service lines, client projects, and staff in a manner that ensures all functions, projects, and tasks are handled with the highest quality, on time and within budget, in a manner consistent with SOP’s, regulations and ICON policies.

Job Description
  • Recognize, exemplify and adhere to ICON's values which centers on Integrity, Inclusion, Agility and Collaboration
  • As a RBQM SME, the employee is expected to recognize the importance of and create a culture of quality in delivery and process improvement with a focus on optimizing and streamlining our processes, adding efficiency and value to our business and meeting client needs.
  • Provide expert RBQM input into new business proposals, budgets and bid defense meetings as applicable.
  • Review protocols and provide expert input into risk identification and associated mitigation strategies
  • Review and assess existing Risk Management SOPs, and components of other SOPs that relate to RBQM. Support in development & review of new Risk Management SOPs, change management, process review & design as well as development of effective training, in line with ICON, Regulatory and Industry requirements
  • Drive innovation and continuous improvement in all areas of responsibility. Maintains awareness of evolutions in technology, sponsor and competitor positions as well as regulations affecting RBQM and lead/support working groups in initiatives for risk-based quality management or related process/system improvement. Drive, analyse and provide input for business cases for development projects in Risk Management or cross-functional projects involving Risk Management.
  • Liaise with sponsors and cross-functional team members on project or program related matters where appropriate.
  • Excellent working knowledge of ICH E6 and ICH E8
  • Travel (approximately 10%) domestic and/or international
  • Other duties as assigned
Requirements:
  • Bachelor's Degree in science, business, medicine or equivalent
  • Strength in risk management, communication, strategy, independent decision-making, negotiation, and conflict management
  • Client facing experience
  • Experience leading a team
  • Knowledge of the clinical trial cycle
  • Subject matter expertise in RBQM
  • Comprehensive knowledge of ICH-GCP
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