Trial Delivery Specialist/ Clinical Trial Coordination, FSP
Work Schedule
Standard (Mon-Fri) Environmental Conditions
Office Job Description
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:
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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.
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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
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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.
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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.
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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.
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Vendor Oversight:
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Responsible for vendor management and CRO oversight , acting as a primary point of contact, overseeing study-specific deliverables.
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Clinical Supplies:
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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.
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e -TMF Data Oversight:
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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.
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Budget/Financial Activities:
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Manage change orders, expenses, and ensuring consistency between systems and agreements, escalating issues to the study stakeholders.
Education Requirements:
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Graduate/Bachelor's degree in life science