Clinical Operations Lead

Clinical Operations Lead

Position Overview

The Clinical Operations Lead (COL) supports the Project Manager in overseeing all clinical aspects of assigned studies. The COL ensures clinical trial activities are conducted according to protocol, regulatory requirements, and company standards, focusing on operational excellence and team coordination.

Key Responsibilities

• Support the Project Manager in planning, executing, and managing clinical studies from start-up through close-out
• Contribute to development and review of key study documents including protocols, ICFs, develop monitoring plans, and operational manuals
• Lead and motivate the clinical team, setting priorities and ensuring clear communication and effective escalation of issues.
• Oversee site activation, study timelines, and deliverables to ensure adherence to project parameters
• Review site visits reports, support CRAs with site monitoring and resolution of site issues, perform co-monitoring visits.
• Facilitate cross-functional and sponsor communication for proactive problem-solving
• Monitor the quality of clinical deliverables, address issues, and identify opportunities for improvement
• Organize and deliver training for the study team on project-specific requirements
• Liaise with Data Manager to provide required data and analyze operational metrics
• Identify and communicate risks and mitigation strategies to the Project Manager and senior staff
• Ensure compliance with protocol, GCP, ICH guidelines, and regulatory requirements
• Support regulatory submissions
• Reviews and QC of Essential Documents in the electronic Trial Master File and ensure completeness
• Support audits and inspections and readiness activities.
• Collaborate with Quality Assurance to address audit findings and implement corrective actions
• Maintain up-to-date project reporting systems for clinical activities
• Interface with functional leads, vendors, and clients as needed; serve as primary liaison for clinical monitoring issues
• Participate in client meetings and presentations as required
• Contribute to the development and improvement of SOPs and operational processes

Interested candidates are invited to submit their resume and cover letter to careers@palleos.com. We look forward to hearing how you can make a difference in our team.