Unblinded Trial Delivery Specialist/Clinical Trial Coordinator - FSP

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: Partner with Global Study Leaders to support end-to-end clinical trial delivery, ensuring alignment with study timelines, quality standards, budgets, and operational objectives. Coordinate cross-functional study activities, oversee CROs and vendors, maintain study documentation and tracking systems, and proactively identify, manage, and escalate risks to successful study delivery. Coordinate unblinded study operations, acting as the primary point of contact for uLDLs and uCRAs, supporting training, study documentation, and cross-functional communication. Oversee unblinded risk management, including protocol deviations, accidental/emergency unblinding, safety escalations, and compliance with SOPs and study procedures. Manage study oversight activities, including CTMS updates, IMP and ancillary supplies, third-party coordination, subject status reconciliation, and operational reporting. Ensure TMF completeness, accuracy, and regulatory compliance through document reviews, quality checks, and CRO oversight. 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 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