Manager* Clinical Data Management
Open for hire at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, London, Berlin VoltAir. - Job ID: 5674
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.
Manager* Clinical Data Management
The Manager* Clinical Data Management provides solid core and comprehensive data management expertise to provide quality data management deliverables on clinical studies. Responsible for the supervision of external sub-contractors that perform data management activities as deemed necessary for the conduct of the project. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
Your main responsibilities are
- Serve as primary point of contact for partners and sub-contractors on data management deliverables and activities
- Provide data management and technical expertise while working with the CRO data managers and key decision makers for end-to-end DM activities
- Oversee clinical data management activities in accordance with BioNTech strategy and standards
- Perform direct negotiations with the CRO for timelines, process and quality issues
- Approve all the data management plan documents (CRF, Validation plan,..)
- Ensure services and quality meet agreed specifications per the DMP and BioNTech quality standards
- Perform ad hoc clinical data reviews and data quality checks
What you have to offer
- Natural / life sciences or scientific background (university degree) or former experience in a CRO/ biotechnology/ pharmaceutical company in a Clinical Data Management position within the EU
- Minimum 5 years of experience in Clinical Data Management with practice in oversight of DM activities as a Lead and DM project management
- Profound knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects and experience with Clinical Database Systems and processes
- Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, etc.)
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, London, Berlin VoltAir. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. 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!