Manager* Clinical Data Management Solutions

Open for hire at one of the following locations –  Cambridge Erie Street, Gaithersburg, Mainz Goldgrube. - Job ID: 4435 

 

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 Solutions 

 

Responsibilities

•    This position will serve as an essential link between CDM Solutions team and CDM portfolio and study leads
•    Support standardized processes and procedures for clinical data collection, cleaning, and reporting.
•    Participate in process improvement and training initiatives within CDM and across functions.
•    Oversee compliance with SOPs, regulatory requirements, Good Clinical Data Management best practices and other applicable industry standards.
•    Maintain awareness of details CDM initiatives and track action items for Clinical Data Management team to review and report accordingly.
•    Lead and support the development, review and implementation of processes, policies, SOPs, and associated documents affecting CDM.
•    Support CDM solution team, identifies and evaluates fundamental issues, providing strategy and direction for major functional areas and lead the effort for improvement and optimization from CDM. 
•    Support standards data governance process, partner with portfolio leads to ensure portfolio specific requirements are met. 
•    Work with CDM solution team to lead or participate in department initiatives, cross-functional working groups and process improvement activities.
•    Assist DM leads in response to CDM process and quality related questions.
•    Support Inspection Readiness activities, build documentation for SOP Deviations and other Quality Events that occur.
•    Execute trainings to data managers when preparing for an audit, inspection, or handling an issue related to process quality/compliance.
•    Continuously monitor and evaluate data management processes to identify areas for improvement and implement best practices.
•    Align efforts with the cross-portfolio clinical data management team to ensure appropriate issue resolution of data quality issues from process and system level. 
•    Support CDM solutions team and, partner with cross function process owners to prepare training documents specific to CDM team
•    Support the adoption of technology improvements and tools clinical data management processes.
•    Support CDM solution team in translating business strategy and function needs into business requirements
•    Provide vendor management oversight, ensuring data management activities for clinical trials are efficiently managed within assigned research program(s) 
•    Study level coordination and hands on CDM tasks, including clinical data review
•    Oversees development of, edit check specifications, CRF Completion Guidelines or Data Entry Guidelines, Data Management Plan, Data Review Guidelines, SAE Reconciliation Plan, to ensure compliance with SOPs and DM process documents

 

Qualifications

 

Education
•    Bachelor’s degree in Natural / life sciences, scientific, or bioinformatics / computer science background (university degree) and former experience in a CRO/ biotechnology/ pharmaceutical company

Experience
•    Experience working in the pharmaceutical industry or other clinical research setting with clinical trials
•    Understanding of US and global regulations and guidelines (e.g., FDA, EMA, MHRA, ICH) applicable to clinical development; 
•    Competent in clinical data management functions, EDC systems, Data Cleaning systems, some experience with standards a plus
•    Preferred experience working in global teams.
•    Must have relevant technical skills, DM process understanding and CRO oversight, Strong QC skills, and broad understanding of regulatory requirements for pharmaceutical/biotechnology industry.
•    Therapeutical area level expertise in Oncology and Infectious disease is a plus.

 

Special Skills
•    Fluent in English (written and spoken)
•    Minimum of five (5) years of clinical research experience
•    Equi