Clinical Research Manager

hace 3 semanas

Colombia ENGINEERINGUK A tiempo completo
Job Summary

As a Clinical Trial Manager, you will be responsible for overseeing the execution of clinical studies in accordance with the global program strategy. This role involves leading cross-functional teams, developing program-specific materials, and ensuring timely delivery of study-specific deliverables.

Key Responsibilities
  • Plan, manage, and oversee clinical study execution in accordance with the global program strategy.
  • Contribute to the development of program-specific materials, such as monitoring plans and study-specific training documents.
  • Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/ies.
  • Contribute to, deliver, and/or lead CRA, Investigator, and Study Coordinator training.
  • Provide oversight and monitoring of applicable vendor activities, such as laboratories and equipment provisioning.
  • Provide country-level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study.
  • Responsible for approval of Baseline and Revised Enrolment Plans (Country Level).
  • Monitor the execution of the clinical study against timelines, deliverables, and budget for that country.
  • Translate global start-up requirements into local country targets.
  • Monitor and act upon data flow metrics - review, trend identification and analysis, with targeted follow-up where appropriate.
  • Identify and facilitate resolution of cross-functional study-specific issues.
  • Escalate any issues related to delivery, timelines, or budget to GCMs (or TMT lead if appropriate).
  • Execute regulatory agency inspection readiness activities (e.g., TMF review, storyboard generation).
  • Collaborate with local teams to ensure country-level study delivery is aligned with global expectations.
  • Identify risk, implement risk mitigation strategies, and resolve issues at a country/site level, as well as informing the CST / TMT, LST, and local teams of risks associated with delivery in a proactive, timely, and solution-oriented manner.
Requirements
  • Bachelor's degree in a health, life sciences, or other relevant field of study.
  • Minimum 5-6 years' work experience in clinical research or knowledge in Project Management and Site Management.
  • CRA Experience preferred.
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.

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.

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