Clinical Data Standards Lead
Nexer Telescope AB / Supportteknikerjobb / Lund
2025-02-04
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Job Description:
You will be working in one of the teams in the software engineering department focusing on patient facing mobile and web application for clinical studies.
Responsibilities:
• Develops and enforces clinical data standards (preferably pulmonary therapeutic area) to enhance the efficiency, productivity, and quality of clinical data deliverables. These standards encompass industry standards like the CDISC SDTM (Study Data Tabulation Model), and ADaM (Analysis Data Model).
• Strong technical expertise and experience in Systems Development Life Cycle (SDLC) principles and product management.
Required skills & experience:
• 8 - 13 years of relevant experience in CDISC SDTM & ADaM.
• Advanced knowledge of clinical programming aspects of clinical research, data management, standards compliance methodologies, metadata management and data analysis
• Advanced knowledge of programming, analysis, and reporting or data collection standards
• Advanced knowledge of CDISC standards for the creation and maintenance of end-to-end standards from data collection to regulatory submission
• Advanced knowledge of all CDISC guidance documents and implementation guides
• Excellent written and oral communication skills, along with ability to present technical issues
• Advanced ability to work with management in the development and collection of metrics
• Advanced ability to collaborate with sponsors on standards implementations
• Demonstrated experience applying at least one data standard such as: CDASH, SDTM and ADaM
• Experience in generating Questionnaire Response Datasets like the QRS dataset.
Desired skills & experience:
• Good knowledge of GCP / ICH guidelines
• Preferably, good knowledge of composite endpoint datasets consisting of multiple event types like Ashma and COPD.
Education/Experience
• 8-13 years of experience in Pharmaceutical industry
• Bachelor's Degree
Please send Your CV to
jobs@telescopeservices.se.
Så ansöker du Sista dag att ansöka är 2025-05-05
E-post:
jobs@telescopeservices.se Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "TSS-DSL-250204".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Nexer Telescope AB (org.nr 556807-2820)
Scheelevägen 16 (
visa karta)
223 63 LUND
Arbetsplats Telescope Services AB
Jobbnummer 9144333