Performs periodic central monitoring of the aggregate data at the study, region, country, site, and patient levels leveraging available analytics/visualizations in the RBQM system to identify emerging risks and/or issues
Leads risk review meetings and discussions with study team members to effectively communicate and discuss the findings, facilitates and encourages robust root cause identification and mitigation strategies
Ensures corrective actions and preventative actions are properly documented, assigned, and implemented by assigned study team members and/or impacted functions
Monitors the effectiveness of study risk mitigation actions in reducing the risk signals; makes recommendations to adjust as needed
Creates signal and trending reports for study teams to support their interpretation of RBQM output
Partners with the Adaptive Monitoring Excellence team for signals requiring review or adjustment to study level plans for targeted source data verification and source data review
Maintains up-to-date, accurate documentation of RBQM activities
Supports and participates in internal and external audits and inspections
Maintains high quality, consistency, and compliance with RBQM procedures across studies
Adjusts RBQM plan appropriately based on both anecdotal feedback and data-driven trends in overall RBQM success measures
Identifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes
Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit
Supports inspections and regulatory interactions as it relates to Takeda’s adoption of RBQM framework
May perform line management of other (junior) staff within RBQM Operations
EDUCATION, EXPERIENCE, KNOWLEDGE, AND SKILLS
Education: Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
Experience
Minimum of 6 years of experience in the pharmaceutical or CRO industry
Minimum of 2 years of experience in Risk Based Quality Management
Minimum of 2 years managerial and supervisory experience
Robust understanding of the drug development process and clinical trial execution
Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
Skills
Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
Knowledge of RBQM IT systems or other data analytic systems
Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
Demonstrated ability to effectively lead cross functional team meetings
Experience forming cross-functional collaborations; strong interpersonal skills
Supports a culture of continual improvement and innovation; promotes knowledge sharing
Ability to influence without authority
Thinks creatively; challenges the status quo
Behavioral Competencies
Pragmatic and willing to drive and support change
Comfortable with ambiguity
Excellent teamwork, organizational, interpersonal, and problem-solving skills
Assertive and collaborative communication style
Aptitude for data analytics; analytical mind
Attention to detail and a critical thinker
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
Ability to effectively communicate cross functionally with people of various levels
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.
At ICON, inclusion & belonging are fundamental to our culture and values. 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.
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
