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 CRO/ biotechnology/ pharmaceutical company in a Clinical Data Management position

 

Experience

•  Minimum qualification with a period (e.g., 3 years in a regulated environment).  At least 15+ years of experience in the pharmaceutical industry or other clinical research setting with clinical trials, at least 5 years working with clinical data management, and 3+ years of supervisory experience are required.

•  Solid understanding of US and global regulations and guidelines (e.g., FDA, EMA, MHRA, ICH) applicable to clinical development; prior success in partnering with regulatory peers to support timely and quality regulatory submissions

 

•  Highly competent in clinical data management, various EDC systems, CDR systems, CDASH/CDISC standards, and medical coding dictionaries.

•  Preferred experience with global teams located in several offices

•  Must have relevant technical skills, DM process build, clinical data standards build and maintenance, CRO oversight, QA/QC, and submission preparation experiences within the pharmaceutical/biotechnology industry.

•  Specific department or therapeutical area level expertise in Oncology and Infectious disease is a plus.

•  Previous experience leading DM efforts for CRO vendor selection and implementation is a plus.

•  Very good English (written and spoken)

•  Proven change management ability at the department or cross-function process implementation level


 

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 – Cambridge Erie Street, London, Mainz GoldgrubeApply 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!