BioNTech SE · 1 day ago
Clinical Trial Specialist
Cambridge, MA
Full-time
Onsite
Entry Level
1+ years expBioNTech SE is a biotechnology company focused on developing and manufacturing innovative therapies. The Clinical Trial Specialist will assist in executing clinical trials, focusing on operational and administrative tasks while ensuring compliance with regulations and guidelines.
Health Care
Responsibilities
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
Qualification
Required
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)
Benefits
Competitive remuneration packages
Company
BioNTech SE
At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
James Ryan
Chief Legal Officer and Chief Business Officer
Recent News
2025-10-21
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