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Clinical Trials Project Lead
hace 2 meses
**Job Summary:**
We are seeking an experienced Clinical Trials Project Lead to join our team in Mexico City. As a Clinical Trials Project Lead, you will be responsible for managing projects in accordance with Good Clinical Practice, ICH, and GCP regulations.
About ICON:
ICON plc is a world-leading healthcare intelligence and clinical research organization. We pride ourselves on fostering an inclusive environment that drives innovation and excellence. Our mission is to shape the future of clinical development, and we welcome talented individuals to join us on this journey.
Responsibilities:
- Manage projects in a timely manner, ensuring client satisfaction and adherence to ICON's SOPs, ICH, GCP, and relevant regulations.
- Deliver projects within the agreed contract timelines and budget.
- Identify out-of-scope activities and initiate budget change orders and contract amendments as needed.
- Attend and present at Investigator Meetings, Client Kick-Off Meetings, and other client meetings.
- Facilitate the electronic endpoint adjudication system for endpoint adjudication projects.
- Ensure all necessary study-specific training is provided to the study team to improve performance and knowledge.
- Develop and maintain all trial documentation, including charters, procedure manuals, site manuals, etc.
- Perform user acceptance testing of the electronic endpoint adjudication system.
- Serve as the primary study contact for clients and internal and external study teams.
- Lead internal and external study team meetings.
- Provide feedback to senior management on project status, metrics, client satisfaction, and staffing issues.
Requirements:
- Bachelor's degree or local equivalent in Science, e.g., Biology, Chemistry, or related field.
- Minimum 2 years of experience working in a clinical laboratory, clinical trials, or customer management/account management role in a life sciences-related organization.
- Minimum 1 year of Project Management experience in a service area serving clinical trials.
- Excellent oral and written communication skills.
