Clinical Data Risk Manager

MEXICO. REMOTE.
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply

Skills
GCP, Data Analysis, Process Improvement, Risk Management, Documentation