Senior Manager - Adaptive Monitoring Excellence

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.

What you will be doing:

• As assigned to support study execution teams, responsible for the implementation of Adaptive Monitoring procedures
  • Interprets critical data, critical processes, and key risks assigned for site monitoring mitigations to determine study specific site monitoring requirements
  • Leads adaptive monitoring strategy meetings, engaging cross-functional study team members to identify study-level SDV and SDR strategies, aligned with adaptive monitoring schemas
  • Ensures risk-based monitoring strategies are integrated and site monitoring functional plans, and ensures strategies are correctly configured in technology solutions (TSDV, Veeva CDMS, CTMS etc)
  • Partners with RBQM Operations team to ensure central monitoring findings and other signals identified for site monitoring mitigation are effectively communicated and addressed by site monitoring teams, documenting any need for the adjustment of source data verification or source data review targets
  • Performs periodic assessment of the compliance with monitoring plans at the study, region, site, monitoring partner and personnel levels, and identifies and escalates issues and emerging monitoring compliance risks to the study execution team
  • Leverages identified signals to coordinate Monitoring Oversight Visit activities for selected studies, and ensures appropriate processing of related visit reports and findings
  • Maintains up-to-date, accurate documentation of Adaptive Monitoring activities
• Maintains high quality, consistency, and compliance with RBQM procedures across studies
• Recommends adaptive monitoring process adjustments based on 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 CQM’s RBQM processes
• Acts as a change agent, champion, subject matter expert and point of contact for adaptive monitoring concepts, leading study teams to understand and follow the best practices to achieve maximum benefit
• Supports and participates in internal and external audits and inspections as related to adoption of RBQM and Adaptive Monitoring

You are:

• Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
• Minimum of 6 years of experience in the pharmaceutical or CRO industry
• Minimum of 2 years of experience in Risk Based Quality Management, Risk-Based Monitoring, or Adaptive Monitoring roles
• Robust understanding of the drug development process and clinical trial execution
• Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP)
• Experience in site monitoring and risk-based monitoring, including onsite and remote monitoring models
• Experience in establishing risk-appropriate monitoring approaches, and assessing site monitoring compliance and quality/effectiveness
• Knowledge of RBQM IT systems, targeted SDV/SDR tracking, and EDC systems
• 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

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, 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.