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Become a member of the BioNTech Family!As part of our team of more than 4,000 pioneers, you'll play a central role in solving some of the greatest scientific challenges of our time. In less than a year, we were able to develop our COVID-19 mRNA vaccine to the highest scientific and ethical standards - by far the fastest vaccine development in the history of medicine.

Our goal is 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. In doing so, we are guided by our three corporate values: innovation, passion and cohesion. If you also want to contribute to giving hope for a healthy future to many people, then we should get to know each other!

Manager, Clinical Data Management Solutions (hybrid/remote)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

Equivalent education, experience and/or training may be substituted for the experience requirement

The ideal candidate will be detail oriented, have excellent organizational skills, be proficient in computer applications (Word, Excel, Oncore™), possess excellent communication and interpersonal skills, be able to maximize resources and be resourceful

Benefits for youBioNTech 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.