(Senior) Manager* Clinical Trials
Open for hire at one of the following locations – Mainz Goldgrube, Cambridge, Gaithersburg, London. - Job ID: 6298
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.
(Senior) Manager* Clinical Trials
Your main responsibilities are:
- Independently leading a cross functional team for study execution for one or several studies. May also support a Assoc. Director on this activity or may be responsible for a smaller program
- Responsible for defining and implementing the study quality standards and study objectives as agreed with the program team
- Responsible for Vendor oversight and issue resolution/escalation for the responsible studies
- Responsible for ensuring study timelines are per plan or mitigations are introduced to limit timeline shifts
- Work with cross functional team and the CRO to prepare and compile documents for ethics committee and health authority submission and study plans
- Planning, review, and conduct of training sessions relevant to the studies as well as team and investigator meetings/PSVs/SIVs
- Delegation and supervision of one or more clinical trial specialists assigned to the studies
- Preparation and presentation of Study status, risks, and mitigations to management and the cross functional teams
What you have to offer:
- A bachelor’s degree in the life sciences or a university degree with experience in a health profession
- Minimum 5 years of professional experience as a Clinical Study Manager, CRA/Clinical Monitor or in a similar function, with at least 3 years managing a cross functional team for study execution (Phase 1-3)
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Experienced in managing vaccine studies is a plus
- Experienced in managing studies in Sub-Saharan Africa is a plus
- Very good knowledge of relevant laws and regulations (e.g. ICH GCP guideline)
- Proactive, independent way of working as well as excellent communication and organizational skills
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, Gaithersburg, London. 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!