Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Trial Delivery Specialist - Clinical Trial Coordination Our client is a leading global biopharmaceutical company advancing vaccines, general medicines, and specialty medicines to prevent and treat disease. As an embedded FSP study delivery partner, you will act as an extension of our client’s global study team. Role Overview: This execution-focused global role drives teamwork across internal and external partners to ensure operational perfection in clinical study management across all phases and therapeutic areas. Working closely with study managers and global study leaders, you will ensure the integrity of trial coordination activities - data eTMF oversight ensuring inspection readiness, vendor management, CRO oversight and project planning - while providing guide support that enables efficient, high-quality study delivery throughout the study life cycle. What You’ll Do: · Work as a partner with the global study leader to monitor study conduct and progress – identify, resolve, and advance risks that impact delivery of the study against quality, timeline, and budget objectives. · Work in close partnership with the global study leaders on end-to end operational study delivery activities, from study set up to study archival, with the focus on setting up, maintaining, and ensuring completeness of internal systems/databases/tracking tools and project plans · Review key clinical documents, including the protocol and informed consent forms, and support the development of study plans including monitoring plans, vendor management plans, protocol deviation management plans, and risk management plans. · Coordinate all study-related activities and handle study cross-functional team’s communication including meetings preparation and scheduling. Facilitate and monitor all communication interactions with internal and external study team members including regulatory, LOC, CROs, and third-party vendor partners to ensure the successful delivery of assigned studies. · Support country oversight activities, acting as a primary point of contact, tracking recruitment progress, data completeness and compliance, local budgets, protocol deviations and import license status. · Vendor Oversight: o Responsible for vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables. · Clinical Supplies: o Oversee delivery of clinical supplies, investigational products (IP) and all study materials provided by external service providers. Alert the study teams to issues or risks to continuity of supplies and recommend proposed actions. · e -TMF Data Oversight: o Responsible for data oversight to ensure the study is inspection-ready. Oversight of eTMF completeness. (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality. · Budget/Financial Activities: o Handle change orders, expenses, and ensuring consistency between systems and agreements, escalating issues to the study stakeholders. Your Career Growth: Our FSP model supports continuous learning and career development by offering employees tailored learning pathways, stretch assignments, and mentorship - this allows FSP professionals to expand their horizons. This role opens multiple career paths. You could progress along the Project Management/Study Operations track or Clinical Research Associate track, based on skill, impact, and business need. Why You’ll Want to Join: Join our FSP Global Study Delivery team and help bring life-changing medicines to patients worldwide. · Global exposure: Work on international clinical studies across phases and therapeutic areas, partner with global teams, CROs, vendors, and country operations. · End-to-end ownership: Contribute to every stage of study delivery, from set-up to close-out. · Analytical & project skills: Strengthen global project management, financial tracking, data analysis, and risk management abilities. Learn new clinical trial technologies like AI platforms to conduct a global clinical trial