Clinical Trial Specialist

Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; New Jersey, US   |   full time   |   Job ID: 11004 

 

 

About this 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. 

  

Your Contribution:

  

• 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 

  

A Good Match: 

  

• 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) 

 

 

Your Benefits:

 

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

 

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

 

How to apply:

 

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

 

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

 

We are looking forward receiving your application.