Clinical Data Standards Governance Officer (m/f/x)
Location
Marburg | Germany
Job description
Clinical Data Standards Governance Officer (m/f/x) page is loaded
Clinical Data Standards Governance Officer (m/f/x)
Apply locations EMEA, DE, Marburg, CSL Behring Americas, US-PA, King of Prussia, CSL Behring time type Full time posted on Posted 2 Days Ago job requisition id R-224729
For our Clinical Development operations department, we are looking for a
Clinical Data Standards Governance Officer (m/f/x)
Fulltime / permanent/ non-tariff
R-224729
The Opportunity
As Clinical Data Standards Governance Officer you will be responsible for developing and maintaining data standards for the collection of clinical study data, standard datasets and their related documentation. You will also contribute to the development of procedural documents to govern the processes around standards development and will be responsible for maintenance of the contents.
The Role
- Your main responsibility in this role will be to support the continuous improvement and evolution of clinical standards framework across all functions in Clinical Development and to collaborate with stakeholders to develop standard electronic Case Report Forms (eCRF) in the eCRF system and associated documentation.
- Another focus will be for you to support the development of unique eCRF forms for new studies to ensure their compliance with the CDISC clinical data acquisition harmonization (CDASH) and SDTM data standards
- As an expert in the field, you will support the set-up/ manage the maintenance of an eCRF global library; including appropriate documentation and publish clinical data standards for data collection and datasets (templates, forms, mapping specifications etc.) with the library
- You will manage the lifecycle of standards and their documentation and ensure alignment with industry standards and best practices and implement, communicate, and train Clinical Development on new and revised data standards
- In order to support the development of acceptances criteria for clinical data deliveries to enable adequate quality control of vendor deliverables you will ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (ie, follow the CDISC standard requirements)
- As a Knowledge Expert to Clinical Development Teams you will support electronic submissions to regulatory authorities with in-depth knowledge of applicable regulatory guidelines and standards and ensure that clinical program teams consider applicable guidelines and standards in the clinical development plan by giving appropriate advice
- You will Contribute to the development and maintenance of Data Management, Clinical Programming and cross functional procedural documents to govern the development and maintenance of data related standards and processes
Your Skills and Experience:
- Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experience (Other degrees and certifications considered, if commensurate with related data management or clinical programming experience)
- At least 8 years of experience in either clinical data management and/or statistical programming, within the CRO/pharmaceutical environment
- Comprehensive understanding of data management processes and standards as well as current regulatory requirements for data management and data standards for submission.
- Understanding of interdependencies of processes in the clinical development process.
- Knowledge of at least one widely used CDMS and preferably experience of working with an EDC platform (Medidata Rave preferred).
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
What we offer
- Innovative work-environment at our R&D campus
- CSL-subsidized company bike leasing
- Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old)
- Access to Gym facility on campus
- 2 Wellness days per year (additional paid time off)
- Family services such as psychological support, legal advisory, family care services and more for you and your direct family
For more information, please check out our global benefits below.
We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here .
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