Associate Clinical Team Lead

This is a fully remote position, open to applicants in Spain, +3 more countries.

📋 Description

• Assist Clinical Team Leaders (CTLs) in the comprehensive execution of clinical projects or programs, ensuring compliance with protocols, timelines, and regulatory standards.

• Monitor and track recruitment efforts, study metrics, oversight activities, and documentation processes.

• Implement ICH-GCP guidelines and ensure that study sites adhere to GCP and relevant regulations.

• Collaborate with cross-functional teams, including data management, regulatory affairs, and safety departments.

• Aid in managing clinical operation timelines, metrics, resources, budgets, and related activities.

• Identify potential risks and implement corrective actions and mitigation strategies.

• Track and reconcile clinical operation budgets, including monitoring visits and Clinical Research Associate (CRA) allocations.

• Facilitate communication among clients, site personnel, and internal teams; escalate issues to CTLs and study teams as necessary.

• Support internal and external meetings and maintain routine communications with clients.

• Assist with training, onboarding, and preparation of training materials for CRAs and IHCRAs.

• Promote collaboration and integration among project teams and study sites.

• Provide performance feedback on CRAs and IHCRAs to line managers and project leaders.

• Assist in the review and reconciliation of protocol deviations.

• Support compliance with project-specific training and development of study protocols and documentation.

• Aid in the planning and execution of on-site Quality Compliance Visits under the guidance of study teams.

• Stay informed about industry trends, regulatory updates, and best practices.

⛳️ Requirements

• Bachelor's Degree, preferably in a life science, nursing, pharmacy, or a related field.

• A minimum of 3 years of clinical research experience in the CRO, pharmaceutical, or biotechnology sectors.

• At least 2 years of experience in on-site monitoring.

• Demonstrated leadership skills with experience managing teams within a CRO or pharmaceutical environment.

• Strong understanding of GCP and regulatory standards.

• Familiarity with clinical trial processes and necessary documentation.

• Excellent interpersonal and communication abilities.

• Capacity to manage multiple priorities and meet deadlines in a fast-paced setting.

• Proactive, solutions-focused mindset with the ability to influence decisions and lead initiatives.

• Experience with clinical trial management software and Electronic Data Capture (EDC) systems.

• CV must be submitted in English.

🏝️ Benefits

• Flexible work-life balance.

• Supportive and collaborative work environment.

• Stability and opportunities for long-term career development.

• Remote work arrangement available.

• Occasional travel for site visits and client meetings.