Trial Delivery Specialist – Clinical Trial Coordination

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

📋 Description

• Serve as an extension of the client’s international study team to guarantee operational excellence in clinical study management across all phases and therapeutic areas.

• Maintain the integrity of trial coordination activities, including data eTMF oversight to ensure inspection readiness, vendor management, CRO supervision, and project planning, while providing guidance that supports efficient, high-quality study delivery throughout the study life cycle.

⛳️ Requirements

• Collaborate closely with the global study leader to monitor study execution and progress, identifying, resolving, and advancing risks that could affect the study's delivery against quality, timeline, and budget goals.

• Work in close collaboration with global study leaders on comprehensive operational study delivery activities, from study setup to archival, focusing on establishing, maintaining, and ensuring the completeness of internal systems, databases, tracking tools, and project plans.

• Review essential clinical documents, including protocols and informed consent forms, while supporting the development of study plans such as monitoring plans, vendor management plans, protocol deviation management plans, and risk management plans.

• Coordinate all study-related activities and manage communication within the cross-functional study team, including preparation and scheduling of meetings. Facilitate and monitor all interactions with both internal and external study team members, including regulatory bodies, LOC, CROs, and third-party vendor partners, to ensure successful delivery of assigned studies.

• Assist with country oversight activities, acting as the primary point of contact, tracking recruitment progress, data completeness and compliance, local budgets, protocol deviations, and import license status.

• Oversee vendor management and CRO supervision, acting as the primary point of contact and ensuring the completion of study-specific deliverables.

• Monitor the delivery of clinical supplies, investigational products (IP), and all study materials provided by external service providers. Notify study teams of any issues or risks to the continuity of supplies and recommend appropriate actions.

• Manage change orders, expenses, and ensure consistency between systems and agreements, escalating issues to study stakeholders when necessary.

🏝️ Benefits

• Global exposure: Engage in international clinical studies across various phases and therapeutic areas, partnering with global teams, CROs, vendors, and country operations.

• End-to-end ownership: Participate in every stage of study delivery, from initiation to close-out.

• Analytical & project skills: Enhance global project management, financial tracking, data analysis, and risk management capabilities.

• Learn new clinical trial technologies, including AI platforms, to facilitate global clinical trials.