Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job Description

Summarized Purpose:

We are looking for a CTC I / II - FSP to join our team at Thermo Fisher Scientific Inc. This role offers an excellent chance for someone ambitious to make a significant impact on the future of clinical trials. Your work will focus on flawlessly executing clinical studies, aligning with our mission to improve global health, cleanliness, and safety.

Essential Functions

• The Clinical Trial Coordinator - Project Specialist is an essential member of the Global Study Team. They contribute to the successful delivery of the clinical study within the specified timeframe, budget, and quality standards. Additionally, they ensure that the study eTMF is complete and inspection-ready.
• Enhance your expertise by implementing standard methodologies, and facilitate knowledge sharing across the business to improve operational delivery efficiency.

• Assist the Study Manager or Study Delivery Lead in managing the operational aspects of study delivery, such as maintaining internal systems, databases, tracking tools, and project plans.
• Collaborate with internal and external partners on clinical study management activities for in-house and outsourced studies across all phases and therapeutic areas.
• Monitor study progress and identify, resolve, and advance risks/issues that impact delivery quality, timeline, and budget objectives.
• Review key clinical documents and lead the development of study plans for external and internal use in assigned studies.
• Facilitate and maintain interactions and meetings with internal and external partners to ensure the successful delivery of assigned studies.
• Coordinate vendor management and CRO oversight, serving as the main point of contact and ensuring the timely completion of tasks assigned to external parties.
• Track recruitment progress, data completeness, compliance, local budgets, protocol deviations, risks, regulatory approvals, and import license status.
• Coordinate study-related activities and manage study team's communication, including meetings, newsletters, action logs, and communication plans.
• Coordinate the delivery of clinical supplies, investigational products, and all study materials, ensuring continuity and proposing solutions for any issues/risks.
• Ensure the study is inspection-ready at all times, coordinating eTMF completeness and following up on missing documents.
• Manage budget oversight, including Task/Change Orders, expenses, and consistency between systems and agreements, advancing issues as necessary.
• Actively contribute to the squads as per STOM requirements.