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Associate Director/Senior Manager, Clinical Data Management

 

ATLAS - Joint PhD Program from BioNTech and TRON with a focus on translational medicine 

 

12 PhD positions in biology, biochemistry, life science, chemistry, medicine, computer science or related fields

BioNTech and TRON (Translational Oncology Mainz) are leading institutions in the field of immunotherapy. Our joint international PhD Program (ATLAS) is looking for talented, junior researchers of all nationalities.
 
Our international PhD program ATLAS (Talent Academy for TransLAtional Science), guides and supports PhD students to conduct excellent research projects and offers comprehensive training in cutting-edge technologies and professional skills. The scientific training within the program has a strong focus on "the art of translation", i.e. turning basic scientific discoveries into applications.
 
We offer the opportunity to work on innovative research projects focused on translational science in the field of medicine. As a PhD student*, you will join a community of world-class scientists working on diverse topics such as:

  • Immunotherapy of cancer, infectious diseases & autoimmunity
  • RNA biochemistry
  • Protein engineering
  • Bioinformatics & systems biology
  • Biomarker research
  • Antimicrobial therapies 

For details on the program and the specific projects, please visit www.atlas-phdprogram.com.

 

Your main responsibilities are: 

•    Organizes and conducts project team meetings.
•    Provides guidance to project teams on the oversight and supervision of CRO/third party vendors and organizes trainings as needed. Acts as a mentor for new incomers or may delegate to appropriate team member this activity. Provides continuous feedback to develop team members. 
•    Contributes to the development and review of portfolio documents (includes contracts, guidelines, budgets, metrics, KPIs..) 

•    Complies with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. 
•    Identifies the needs of new technology or tools for Data Management and takes active role during  development and implementation. 
•    Supervises clinical data management activities within his/her portfolio/platform program and ensures it is per BioNTech standards and strategy. 
•    Escalates unresolved data or compliance issues to the functional manager(s).
•    Provides guidance to Subject Matter Experts with regard to standard process developments.
•    Ensures the trials processes are aligned within his/her portfolio/platform program(s) and escalates any deviations or foreseen non-compliance.
•    Provides expert support to the Clinical Development Team, on study design issues for BioNTech development projects and portfolio/platform program(s).
•    Represents his portfolio/platform program(s) team among other department leads and functions, and supports cross-functional interactions and problem solving.
•    Participates in strategic vendor selection processes for Clinical Data Management, and actively participate in vendor relationship management, includes escalation.
•    Provides input on developing, revising, and maintaining core operating procedures and templates.
•    Provides support or assist Quality assurance department in conducting audits involving data management activities.


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  
•    Minimum 8-10 years of experience in Clinical Data Management with wide 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 Clinical Database Systems and processes
•    Experience in leading project teams and resource planning
•    Mandrin is must-have; Very good English (written and spoken)
•    Effective communicative skills, active listener
•    Excellent organizational skills
•    Able to motivate and lead a team/ used to work in a team
•    Able to work under stressful conditions
•    Ready to take over responsibilities
•    Able to recognize problems and provide solutions
•    Detail oriented
•    Experience in usual software (Word, Excel, Power Point)
•    Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, …)
•    Independent and pro-active way of working


 

Who can apply?

 

Aspiring students seeking to advance knowledge and explore novel therapies. The requirements are:

  • Master’s degree (or equivalent) in biology, biochemistry, life science, chemistry, medicine, computer science or related fields
  • Good command of English



We Offer:

 

  • A highly collaborative and interdisciplinary research environment at the interface between academia and pharmaceutical applications
  • A doctoral degree awarded by a partnering university (e.g. Mainz University)
  • Dedicated supervision by leaders in their fields with a strong publication record
  • Cutting-edge technologies and in-house services to support your research
  • Extensive curriculum for scientific, technical and professional skills
  • Excellent working conditions:
    • Fully funded PhD positions (contracts will be from either BioNTech or TRON)
    • Family-friendliness
    • Open and inclusive culture
    • An international environment with English as our working language



Have we piqued your interest?

 

Then apply now for our location in Mainz, Germany and simply send us your application documents using our online form.
 
The deadline for applications is January 15th, 2023. Interviews will take place in Mainz on March 9-10th, 2023.

If you have any further questions, please visit www.atlas-phdprogram.com  or email us at info@atlas-phdprogram.com.

We look forward to your application!
  
Please note that your application and data will be used by both BioNTech and TRON – for further information on the data protection policy please go to www.atlas-phdprogram.com

*BioNTech and TRON do not 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!

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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, encourage creativity, 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!  

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