Clinical Trial Specialist

BioNTech; Greater London; On-site; GBP 60,000 - GBP 80,000; Full time

Job summary

A leading biotechnology company is seeking a Clinical Trial Specialist to assist in executing clinical trials with operational and administrative focus. Responsibilities include coordinating study-related documents, overseeing training, and ensuring compliance with regulations. The ideal candidate will have a bachelor's degree, clinical trials experience, and strong project management skills. Competitive remuneration and a commitment to diversity are offered in a dynamic work environment.

Benefits

Competitive remuneration packages

Support for diverse employee base

Commitment to wellbeing

Qualifications

• Bachelor’s degree is preferred.
• Minimum of one (1) years of relevant work experience may be considered.
• Knowledge of ICH-GCP guidelines.

Responsibilities

• Coordinate study-related documents like feasibility questionnaires.
• Assist in planning and conducting project training before activities.
• Organize trial team meetings and ensure adherence to regulatory requirements.

Skills

Clinical trials experience

Project management

Analytical skills

Problem-solving abilities

Teamwork

Time management

Proficiency in English

Education

Bachelor’s degree

Advanced degree in a related field

Job description

Overview

Select how often (in days) to receive an alert:

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.

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

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)

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.

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.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragecreativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!