Clinical Trial Coordinator

Thermo Fisher Scientific · Milan

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Job Description

Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation

What You'll Do

Clinical Trial & Documentation Support

• Coordinate and complete assigned clinical trial activities in accordance with the study task matrix.
• Perform Country and Investigator file reviews and document findings in the appropriate systems.
• Support audit and inspection readiness by ensuring study files are reviewed according to applicable schedules and procedures.
• Ensure assigned activities are completed on time and to a high-quality standard, proactively communicating potential risks to project leads.
• Process and maintain clinical trial documentation within the electronic Trial Master File (eTMF).
• Review eTMF documentation and support the resolution of missing, incomplete, or outstanding documentation.
• Analyze findings reports and assist with the clarification and resolution of site documentation findings.
• Support the preparation, compilation, and distribution of Investigator Site Files (ISFs), pharmacy binders, and study supplies.
• Assist with study-specific translations and translation quality control, as required.

Site Activation & Regulatory Support

• Provide administrative support for site activation and start-up activities.
• Work with internal teams to help ensure site start-up activities remain aligned with the site's activation critical path and project timelines.
• Support regulatory submissions and the tracking of local regulatory documentation.
• Transmit required documentation to clients and centralized Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), as applicable.
• Maintain accurate and timely records of site communications, contact attempts, follow-ups, and survey responses.
• Review survey information to help ensure responses are complete, accurate, and relevant.
• Support effective site follow-up plans and escalate concerns or potential risks appropriately.
• Liaise with relevant internal teams to support the timely resolution of investigator queries.

Systems & Study Coordination

• Provide support for clinical trial systems such as Activate, eTMF, and other study platforms.
• Help ensure study databases and systems remain accurate and up to date.
• Maintain study-specific documentation, team lists, project training requirements, activity plans, and vendor trackers.
• Support Risk-Based Monitoring (RBM) activities where applicable.
• Assist with scheduling internal and client meetings as required.
• Support study communications, including document distribution, reports, and project-specific mailings.
• Collaborate closely with project team members to achieve targeted study milestones and deadlines.
• Communicate site-related issues and potential risks to appropriate clinical and project colleagues.

What We're Looking For

Minimum Qualifications

• High school/secondary school diploma or equivalent relevant academic or vocational qualification.
• Additional university-level education in life sciences, healthcare, or a related discipline is an advantage.
• Previous relevant experience may be beneficial; however, candidates who demonstrate the appropriate knowledge, skills, and motivation to develop within clinical research may also be considered.
• Equivalent combinations of education, training, and directly related experience may be considered.

Preferred Skills & Experience

• Strong organizational skills and excellent attention to detail.
• Ability to manage multiple tasks efficiently while working to project deadlines.
• Ability to analyze project-specific information and systems to ensure accuracy and completeness.
• Strong customer-focused mindset.
• Flexibility and adaptability to changing priorities and study timelines.
• Interest in developing a strong working knowledge of ICH-GCP, applicable Italian and European regulations, and clinical research procedures.
• Good written and spoken English, together with proficiency in the local language as required.
• Effective written and verbal communication skills.
• Strong interpersonal skills and the ability to collaborate effectively with cross-functional and international teams.
• Good computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to quickly learn and confidently work with clinical trial databases and systems.
• Good judgment, problem-solving, and decision-making skills.
• Ability to follow study-specific procedures and project instructions accurately.
• Ability to identify potential risks and escalate them appropriately.
• Self-motivated with a positive and proactive approach to work.
• Ability to work effectively both independently and as part of a team.

Working Environment & Travel

This position is primarily performed in an office and/or home-office environment, depending on business requirements.

• Regular travel is not a core requirement of the role.
• Occasional travel or driving to clinical trial sites may be required depending on study needs.
• The position provides exposure to a wide range of clinical trial activities, systems, and cross-functional teams, supporting continued development within clinical research.

Why Join Thermo Fisher Scientific?

When you join Thermo Fisher Scientific, you become part of a global team committed to accelerating scientific discovery and improving patient outcomes.

We offer:

• An excellent opportunity to build and develop your career in clinical research.
• Exposure to international clinical trials and global project teams.
• Hands-on experience across site activation, regulatory documentation, clinical trial systems, and study management activities.
• A collaborative and inclusive environment where you can learn from experienced clinical research professionals.
• Continuous learning, professional development, and opportunities for career progression.
• Competitive compensation and benefits.
• The opportunity to contribute to clinical research that can make a meaningful difference in patients' lives.

If you're organized, detail-oriented, motivated to learn, and excited about developing your career in clinical research, we'd love to hear from you.

Apply today and help us deliver tomorrow's breakthroughs.

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