Clinical Trial Leader - Remote

Overview

As Clinical Trial Leader, your role is essential to providing oversight to the Clinical Research Associates (CRAs) and other clinical functional groups within the study Team. You will play a major part in ensuring day-to-day clinical trial activities are being adhered to for assigned regional, global, and multi-country trials.

In Short

• Manage the trial start up and site activation process through to close out activities.
• Oversight of critical documentation collection, maintenance and filing.
• Develop the Monitoring Plan and site monitoring templates and tools.
• Site & Investigator Selection, Initiation Management and report review & approvals.
• Responsible for timelines, budget and quality of Clinical Monitoring team deliverables.
• Monitors and manages trial materials supplies.
• Oversees the process of protocol deviation and Trial non-compliance documentation.
• Coordinates and provides support for trial related audits & inspections.
• May provide input into proposals and participate in presentations to potential clients.
• Supports PM in the management of trial vendors as required.

Requirements

• Experience managing US based trials.
• Fluent in Portuguese and English, both written & verbally.
• Strong project management skills.
• Ability to work with minimal supervision.
• Experience in clinical trial operations.
• Strong communication and leadership skills.
• Knowledge of regulatory compliance in clinical trials.
• Experience in risk management and issue escalation.
• Ability to mentor and support team members.
• Proficiency in clinical trial management systems.

Benefits

• Opportunity to work with a global team.
• Engagement in life-changing clinical trials.
• Professional development and training opportunities.
• Collaborative work environment.
• Competitive salary and benefits package.