Clinical Study Manager

hace 1 semana


Xico, México Icon A tiempo completo
About the Role

As a Site Management Associate at ICON, you will play a crucial role in managing, implementing, and monitoring clinical studies. You will be responsible for ensuring the smooth execution of studies, from site activation to close-out. Your primary focus will be on managing electronic Trial Master Files, conducting remote site monitoring visits, and performing periodic quality checks.

Key Responsibilities
  • Manage electronic Trial Master Files, performing periodic quality checks and site-level maintenance.
  • Conduct remote site monitoring visits and/or targeted on-site visits as needed.
  • Manage payments process and FUP, ICFs adaptations/review at site level, Ethics Committees annual renewal and progress/annual reports, site & study close out related tasks.
  • Perform study tracking CTMS.
  • Act as primary site contact/liaison for study and site management issues, including addressing questions, managing study supplies, and conducting offsite central monitoring visits and contacts.
  • Evaluate and escalate issues and risks as needed.
  • Provide training and mentoring to less experienced team members.
  • Support functional team lead in supporting sponsors, including clinical budget management, vendor support/management, and evaluation of metrics to identify process improvements.
  • Contribute to business development activities by participating in proposals and bid defenses.
Requirements
  • Bachelor's Degree, preferably in health/sciences.
  • In-depth knowledge of the drug development process.
  • +3 years experience in a similar position.
  • Knowledge about ethics committees and MOH submissions for protocols, amendments, investigator brochure, and ICFs.
  • In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements.
  • Advanced English level (oral and written) – mandatory.
  • Monitoring/remote monitoring experience (recommended for level I – mandatory for senior).
  • Good leadership skills, advanced critical thinking, as well as strong organization, communication, and time management skills.
About ICON

ICON 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 offer a range of benefits, including various annual leave entitlements, health insurance offerings, competitive retirement planning, and a global Employee Assistance Programme. We're committed to providing a workplace free of discrimination and harassment, and we're an equal opportunity and inclusive employer.


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