Clinical Data Risk Manager

hace 3 semanas

Ciudad de México, Ciudad de México ICON Plc A tiempo completo

Clinical Data Risk Manager - Homebased or hybrid - Mexico City
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.
We have an incredible opportunity for a Clinical Data Risk Manager to join ICON's Full Service IOD Clinical Risk Management team. The CDR M is a clinical risk management and central monitoring functional lead of multiple high complexity studies. The CDRA is responsible for clinical data analysis components of clinical studies, including RBQM facilitation, planning, selection of KRIs focusing on identified risks, advanced analytics design and programming specifications, review of centrally aggregated data to identify risk and issues impacting data integrity, patient safety, and regulatory compliance.
What you will be doing:

  • Signal tracking, system user support, and communication of trends to internal and external stakeholders
  • Conducting QC and oversight activities within the Central Monitoring team
  • Coordinating Central Monitoring sub-teams working with Sponsor specific process
  • Contributing to team development
  • Leading risk assessments on clinical trial data to identify, evaluate, and mitigate potential risks
  • Developing and implementing risk management frameworks and protocols in alignment with regulatory standards
  • Collaborating with stakeholders to ensure effective communication of risk findings and recommendations
  • Monitoring data quality and compliance throughout the trial lifecycle, reporting on risk status and action plans
  • Providing training and guidance to teams on best practices for data risk management
Your profile:
  • 8 + years of experience in clinical data analysis or risk management in a clinical research organization or pharmaceutical company
  • Strong analytical skills with proficiency in statistical software and risk assessment methodologies
  • Attention to detail and a proactive approach to identifying and addressing data risks
  • Knowledge of at least 1 Clinical Data Management System (Medidata RAVE, InForm, Veeva, Cluepoints, Medidata Detect, JReview, etc.)
  • Ability to manage multiple studies simultaneously while handling changing priorities and competing deadlines
  • Excellent written and oral communication skills
  • Bachelor's degree or local equivalent (in life sciences or related field preferred)
  • Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write, and speak fluent English and host country language.

* Please submit all applications in English
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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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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

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