Clinical Trial Specialist

Role Summary

Location:

Cambridge, US;
Gaithersburg, US;
London, United Kingdom;
Mainz, Germany;
New Jersey, US. This is a full-time role. The Clinical Trial Specialist assists the Manager, Clinical Trials or Associate Director, Clinical Trials in executing clinical trials, with a primary focus on operational and administrative aspects. This includes preparing and processing national and international project documents or processes in compliance with local laws, international guidelines (ICH-GCP), and applicable SOPs. This role also performs project-related activities within the specified timelines under the supervision of the Manager, Clinical Trials.

• Coordinate study-related documents such as feasibility questionnaires, Study Management Plans, Monitor Manuals, etc.
• Support the coordination and/or review of clinical trial documents, e.g., synopsis, investigator brochures, patient informed consent documents, etc.
• Assist in the planning and conduct of project training prior to the initiation of project activities; oversee the training matrix and ensure document completion by team members
• Organize, document, and conduct trial team meetings
• Contribute to Trial Master File setup, maintenance, and close-out (paper or electronic) during the clinical trial and perform regular QC checks
• Support the organization and participation in investigator meetings
• Coordinate contract negotiations with trial sites, pharmacies, and local labs
• Assist with internal or site audits and/or inspections within the scope of a project
• Ensure adherence to regulatory requirements, ICH-GCP guidelines, and respective procedures (e.g., policies, SOPs, instructions)
• Enable the Clinical Operations study team to work efficiently and in an organized manner

• Bachelor’s degree is preferred
• An advanced degree in a related field with a minimum of one (1) years of relevant work experience may be considered
• Experience in clinical trials, including practice in project planning and structuring
• Knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for conducting clinical research projects
• Ability to recognize problems and identify solutions collaboratively with the project team
• Demonstrated use of project management skills, including teamwork, analytical and problem-solving abilities, time management, and organizational skills
• Proactive approach to work, with the ability to begin working independently
• Strong proficiency in English (written and spoken)