Job Description
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Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
We are seeking a Senior Data Standards Expert to join our dynamic Data Standards & Integration team within the Data Monitoring, Management and Innovation department. As a Senior Data Standards Expert, you will utilize your extensive knowledge of CDISC standards including CDASH, SDTM, and ODM-XML to support our diverse clinical development portfolio.
Your role:
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Accountable for creating CRF study metadata for the eDC in compliance with internal and CDISC-CDASH standards, coordinating with stakeholders to optimize data standards and processes
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Responsible for participating in study set-up activities, including discussions between CRO, internal study teams, and coordinating stakeholder engagements to define and optimize data standards and processes
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Manage and oversee CRO and vendor performance, including participation in selection/assessment and budget management as required, for assigned trial(s)/projects
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Contribute to the development, maintenance and optimisation of CRF and Non-CRF data collection standards, and SDTM standards, along with maintaining the standards library in the metadata repository
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Ensure Submission Readiness for outsourced studies, preparing SDTM packages for marketing authorization submissions and ensuring compliance with submission rules.
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Foster innovation through new technologies and processes, working with cross-functional colleagues to enhance CRF/Non-CRF and SDTM data standards and procedures in adherence with the governance framework for clinical data standards and change management
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Contribute to the development and maintenance of data management SOPs, work instructions, and best practices.
Who you are:
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Bachelor's or Master's degree in a scientific or technical discipline, preferably in life sciences, data management, computer sciences or a related field
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Proven experience in the pharmaceutical/biotechnology industry, equivalent to 10 years and in Data Standards Development and Governance, equivalent to 8 years
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Minimum of 10 years of experience in Standards Management withData Management or similar discipline within the pharmaceutical, biotechnology, or healthcare industry
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Committed to continuous personal and professional development, and bringing external insights to the role to drive innovation and process improvement
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Strong project management, analytical, communication, collaboration, and problem-solving skills
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Ability to work proactively and independently on assigned tasks or projects of varying complexity
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Extensive knowledge, and demonstrated experience in implementing CDISC CDASH, SDTM, ODM-XML, and define.xml standards (ADaM knowledge is an advantage)Proven track record in effectively managing data standards projects and aiding their implementation; strong attention to detail and a focus on delivering high-quality and consistent data standards
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Ability to adapt to evolving CDISC standards / tools and health authorities' requirements and apply them effectively in practical settings
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Ability to communicate clearly and concisely, both verbally and in written communication, to effectively convey data standards guidelines and requirementsProficiency with clinical data management systems such as InForm or Rave, specifically in eDC study set-up is preferred
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English fluent
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
.
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
We are seeking a Senior Data Standards Expert to join our dynamic Data Standards & Integration team within the Data Monitoring, Management and Innovation department. As a Senior Data Standards Expert, you will utilize your extensive knowledge of CDISC standards including CDASH, SDTM, and ODM-XML to support our diverse clinical development portfolio.
Your role:
-
Accountable for creating CRF study metadata for the eDC in compliance with internal and CDISC-CDASH standards, coordinating with stakeholders to optimize data standards and processes
-
Responsible for participating in study set-up activities, including discussions between CRO, internal study teams, and coordinating stakeholder engagements to define and optimize data standards and processes
-
Manage and oversee CRO and vendor performance, including participation in selection/assessment and budget management as required, for assigned trial(s)/projects
-
Contribute to the development, maintenance and optimisation of CRF and Non-CRF data collection standards, and SDTM standards, along with maintaining the standards library in the metadata repository
-
Ensure Submission Readiness for outsourced studies, preparing SDTM packages for marketing authorization submissions and ensuring compliance with submission rules.
-
Foster innovation through new technologies and processes, working with cross-functional colleagues to enhance CRF/Non-CRF and SDTM data standards and procedures in adherence with the governance framework for clinical data standards and change management
-
Contribute to the development and maintenance of data management SOPs, work instructions, and best practices.
Who you are:
-
Bachelor's or Master's degree in a scientific or technical discipline, preferably in life sciences, data management, computer sciences or a related field
-
Proven experience in the pharmaceutical/biotechnology industry, equivalent to 10 years and in Data Standards Development and Governance, equivalent to 8 years
-
Minimum of 10 years of experience in Standards Management withData Management or similar discipline within the pharmaceutical, biotechnology, or healthcare industry
-
Committed to continuous personal and professional development, and bringing external insights to the role to drive innovation and process improvement
-
Strong project management, analytical, communication, collaboration, and problem-solving skills
-
Ability to work proactively and independently on assigned tasks or projects of varying complexity
-
Extensive knowledge, and demonstrated experience in implementing CDISC CDASH, SDTM, ODM-XML, and define.xml standards (ADaM knowledge is an advantage)Proven track record in effectively managing data standards projects and aiding their implementation; strong attention to detail and a focus on delivering high-quality and consistent data standards
-
Ability to adapt to evolving CDISC standards / tools and health authorities' requirements and apply them effectively in practical settings
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