Clinical Data Management System Lead

Clinical System Lead - Mexico/Colombia

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 System Lead to join ICON’s Full Service IOD Clinical Data Science team. The Clinical System Lead (CSL) will lead and direct one or more Clinical Data Science (CDS) project teams engaged in the initiation, planning, set up, maintenance, control, and closing of systems used in clinical trial projects.

Location:

• Mexico City (office-based with remote flexibility)
• Colombia (home-based or office-based with remote flexibility)

What you will be doing:

• Serve as the main contact for both internal and external customer teams on assigned studies
• Co-lead Kick-Off meetings with internal teams, external partners, and vendors
• Review CRFs and other documents related to clinical system development
• Collaborate with the build team to plan and schedule specification, programming, validation, and ongoing delivery tasks
• Supervise testing and user acceptance testing (UAT) for clinical system components
• Monitor and inform management and relevant study stakeholders of any issues that could impact project deadlines, scope, or budget, and escalate potential problems
• Work independently and with other project leads to negotiate timelines and deliverables with clients and external customers
• Assist in managing system integration setup and vendor interactions as needed
• Understand the revenue recognition and forecasting process at the project level and provide input on actual and forecasted units/hours to the Clinical Data Science Program Manager
• Travel domestically and internationally, approximately 15% of the time

Your profile:

• 2+ years of Clinical Data Management experience
• Clinical Data Management experience with a focus on study startup tasks including but not limited to EDC Design, user acceptance testing (UAT), and data transfer requirements
• Proficiency with at least one ICON preferred Clinical Data Management System (e.g., Medidata Rave, Inform, ClinInfo, Veeva EDC)
• Basic Project Management skills, such as timeline creation and tracking
• Ability to react quickly and adapt to changing requirements, processes, and timelines
• Excellent written and verbal communication skills
• Bachelor’s degree or local equivalent
• 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 *

#LI-Hybrid

#LI-TCT1

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