Director, Clinical Data Management Solutions

Open for hire at one of the following locations –  Cambridge Erie Street, London, Mainz Goldgrube. - Job ID: 7549 

 

Join our team of pioneers!

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.

 

Director, Clinical Data Management Solutions 

 

Your responsibilities may include:

•  Align efforts with the cross-portfolio clinical data management team to ensure the appropriate issue resolution of data quality issues from the process and system levels.

•  Provides industry-level Clinical data management expertise to influence and design the CDM process for clinical data cleaning and quality framework in collaboration with the BNT leadership team and cross-functional team.

•  Support Sr. D of the CDM solution team, partner with cross-function process owners, and train the CDM group in process communication and training.

•  Support Sr. D of the CDM solution team and/or Head of CDM, work closely with Digital, Data, and Informatics (DDI) team regarding design and execution of high-value digital solutions per BNT vision. Develops implementation and operational processes and provides support to DDI team for system implementation and data governance at the R&D level.

•  Support Sr. D of the CDM solution team, build strong relationships with key personnel and cross-functional team acting as CDM Subject matter expert during the process and system creation/optimization.

•  Champion and adopt technology improvements and tools for use in clinical data management processes.

•  Act as CDM subject matter expert, drive Transformation Initiatives in partnership with the business and leverage technical and functional expertise across Clinical development operations, Clinical development, DDI, Safety, GBS, etc.

•  Support and partner with the senior business leadership, function stakeholders and appropriate Digital groups to manage successful execution of the strategy including solution delivery, business adoption and business case achievement.

•  Serve as CDM SME, be a proactive thought leader partnering with portfolio/functions leadership teams to drive innovative use of processes, technology, data, and/or digital (existing, new) to create value and superior experiences for BNT colleagues.

•  Support Sr. D of CDM solution team, translate business strategy and function needs into business requirements.

•  Promotes and leads standardization, automation, innovation, implementing policies, clinical data standards and process improvement, and technology enhancement in Clinical Data Management and beyond to increase drug development efficiency.

•  Support Sr. D of the CDM solution team, identify and evaluate fundamental issues, provide strategy and direction for major functional areas, and lead the effort for improvement and optimization from CDM.

•  Represent CDM, defining standard collection and mapping data definitions, ensuring alignment with industry (CDISC) standards and Health Authority regulations.

•  On behalf of CDM, support standards data governance creation reviews and partner with the portfolio lead to ensure that portfolio-specific requirements are met.

•  Work with Sr. D of CDM solution team and/or Head of CDM, Lead or participate in department initiatives, cross-functional working groups, and process improvement activities.

 

Qualifications

 

Education

•  Natural / life sciences, scientific, or bioinformatics/computer science background (university degree) or former experience in a