Unblinded Trial Delivery Specialist/Clinical Trial Coordinator - FSP

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific Inc., you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital, and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. 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 collaboration across internal and external partners to ensure operational excellence 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 expert support that enables efficient, high-quality study delivery throughout the study life cycle. Responsibilities: Work as a partner with the global study leader to monitor study conduct and progress – identify, resolve, and escalate 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 manage 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: Responsible for vendor management and CRO oversight , acting as a primary point of contact, overseeing study-specific deliverables. Clinical Supplies: 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: 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: Manage change orders, expenses, and ensuring consistency between systems and agreements, escalating issues to the study stakeholders. Education Requirements: Graduate/Bachelor's degree in life sciences or other related fields. Experience: At least 1+ years of relevant work experience in a pharmaceutical/scientific environment. Foundational knowledge of clinical study delivery processes, including regulations and industry standards. Strong project management skills and excellent verbal and written communication in English. Other Skills: Good knowledge of applicable clinical trial regulatory requirements. Ability to manage multiple competing priorities and work independently. Excellent collaborator coordination and communication abilities. Proficient in Microsoft Office tools and clinical trial management systems. What We Offer: Opportunity to contribute to life-changing therapies. Comprehensive training and development programs. A collaborative and inclusive work environment. Attractive compensation and comprehensive perks 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