Specialist* Clinical Trials

Open for hire at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, Cambridge Hamilton Street, Cambridge Sidney Street, Gaithersburg. - Job ID: 2365
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Specialist* Clinical Trials
The Specialist* Clinical Trial is supporting the Clinical Trial Manager* or Associate Director* Clinical Trials in the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of 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 activities related of a project in the timelines specified for the project under supervision of the Clinical Trial Manager.
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.
• Coordination of biomarker sample/requisition logistics in partnership with related functions
• 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
• Communication to other departments regarding information and material transfer to ensure appropriate TMF documentation
• 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

• University degree in natural/life sciences or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant
• 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)
  

Benefits for you
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.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, Cambridge Hamilton Street, Cambridge Sidney Street, Gaithersburg . Apply now for your preferred job and location through our careers site .

• BioNTech does not differentiate on the basis of race, colour, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, veteran status, genetic information, or any other characteristic protected by applicable law. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!