Clinical Data Risk Manager - Mexico

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.

Objectives

This position reports to a Director of RBQM Operations and is responsible for successfully implementing and coordinating RBQM procedures at the study level, including initial and recurring risk identification, assessment, centralized risk monitoring, and mitigation activities within the RBQM framework.

Accountabilities

- Responsible for the implementation of RBQM procedures for assigned studies

- Reviews study protocol and facilitates development of the Study Risk Assessment that defines critical data, critical processes, and meaningful key risk indicators including quality tolerance limits in collaboration with the study team
- Develops study specific content and leads RBQM training and RBQM kick-off meetings
- Authors and implements the study specific RBQM plan
- Leads risk assessment meetings, engaging cross-functional study team members to identify Critical-to-Quality (CtQ) risks throughout the trial lifecycle
- Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system
- 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
- Versátil 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

📌 Sr. Manager - RBQM Operations (México)
🏢 ICON Strategic Solutions
📍 México