Clinical Team Lead

This is a fully remote position, open to applicants in Spain.

📋 Description

• Oversee the comprehensive clinical execution of projects with moderate complexity and scope, and/or assist a senior-level Clinical Team Lead (CTL) on more intricate or larger projects, ensuring compliance with protocols, timelines, and regulatory standards.

• Manage recruitment processes, monitor study metrics, and oversee documentation tasks. With guidance, pinpoint challenges and assist in implementing solutions.

• Ensure that sites adhere to Good Clinical Practice (GCP) and relevant regulations.

• Collaborate with cross-functional teams (such as data management, regulatory affairs, and safety) to ensure successful study deliverables.

• Develop and manage clinical operation timelines, metrics, resources, budget, and activities for projects of moderate complexity and scope. May also support senior CTLs on more complex or larger projects.

• Identify potential risks and escalate them to relevant stakeholders, fostering collaboration and leading the implementation of corrective actions and mitigation strategies.

• Oversee the tracking and reconciliation of clinical budgets related to operational activities such as monitoring visits and CRA allocations. Identify potential budget discrepancies and escalate to the appropriate stakeholders to ensure timely corrective actions are taken and cost-effectiveness is preserved.

• May assist with strategic planning for RFPs, budget creation, and response narratives.

• Conduct monthly assessments of CRA resource projections based on study parameters (e.g., active sites, anticipated Days On Site, upcoming milestones). Collaborate with CRA Line Management to proactively confirm resource needs.

• Act as the primary clinical liaison among clients, site personnel, and internal teams for projects of moderate complexity.

• Facilitate internal and external meetings.

• Manage routine communications with clients and assist in setting client expectations.

• Communicate effectively with site staff as necessary, serving as an escalation point for CRAs when issues arise.

• Lead CRAs and IHCRAs, including project training and onboarding activities.

• Design and conduct training sessions, including investigator meetings, conferences, and team training.

• Provide constructive performance feedback regarding CRAs/IHCRAs to line managers and project leads.

• May participate in Bid Defense Meetings to present clinical operation and monitoring strategies.

• Engage in upfront planning and identification of Protocol Deviations, supporting the finalization and maintenance of the Protocol Deviation Plan and related tasks.

• Oversee the review and reconciliation of protocol deviations throughout the study, ensuring timely documentation and resolution in collaboration with cross-functional teams and clients for projects of moderate complexity.

• Support the identification and ongoing assessment of clinical risks throughout the study, contributing to the development and implementation of risk mitigation strategies for projects of moderate complexity.

• Provide expert review and development of study protocols and related documents and materials (e.g., clinical monitoring plans, protocol deviation plans, case report forms).

• Conduct on-site Quality Compliance Visits to evaluate data across CRAs using a targeted, adaptive, and/or risk-based approach focused on critical and safety-related data points. Identify trends and potential quality issues, escalating as necessary, and collaborate with CRAs and study teams to implement corrective and preventive actions.

⛳️ Requirements

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

• A minimum of 5 years of clinical research experience in the CRO, pharmaceutical, or biotechnology sector.

• At least 2 years of experience as a clinical team lead is preferred.

• A minimum of 2 years of on-site monitoring experience.

• Proven leadership skills with experience in guiding teams within a CRO or pharmaceutical environment.

• Strong understanding of GCP and regulatory requirements, along with familiarity with clinical trial processes and documentation.

• Excellent interpersonal and communication abilities, capable of building relationships with clients and teams.

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

• A proactive, solutions-driven mindset with the ability to make decisions and lead initiatives.

• Experience in using clinical trial management software and EDC systems.

🏝️ Benefits

• Flexibility: We promote a work-life balance that allows employees to bring their best selves to work while nurturing their passions outside of work.