Specialist Clinical Trials

London, United Kingdom; Mainz, Germany   |   full time   |   Job ID: 9112 

As Specialist Clinical Trials, you will assist the Manager Clinical Trials or Associate Director Clinical Trials in executing clinical trials, with a focus primarily on operational and administrative aspects. This includes preparing and processing national and international project documents or processes under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. In this role, you will also perform project-related activities of a project in the timelines specified for the project under supervision of the Manager Clinical Trials.

Your main responsibilities are

• Coordination of study related documents such like feasibility questionnaires, Study Management Plan, Monitor Manual, etc.

• Support in coordination and/or review of clinical trial documents, e.g. synopsis, investigator’s brochure, patient informed consent documents etc.

• Support the planning and conduct of project training prior to the initiation of project activities; oversight of training matrix; documents completion by team members

• Organization, documentation and conduct of trial team meetings

• Contribute to Trial Master File set-up, maintenance and close-out (paper or electronic) during the clinical trial and perform regular QC check

• Support organization and participation in investigator meetings

• Coordination of contract negotiations with trial sites/ pharmacies/ local labs

• Support internal or site audits and/or inspections in the scope of a project

• Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)

• Enable the Clinical Operations study team to work in an efficient and organized manner

What you have to offer

• 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

• Demonstrate some use of Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills

• Experience in clinical trials with practice in project planning and structuring

• Knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects

• Able to recognize problems and identify solutions together with the project team

• Pro-active way of working, starting to work independently

• Very good 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.