Overview
In this role you will establish and govern SDTM standards to ensure data quality and consistency across trials. You will oversee sponsor activities with Biometrics vendors and align data collection with standard frameworks. You will share subject-matter expertise on data standards and support regulatory submissions. You will partner with Digital Solutions and IT to advance technology-enabled approaches in clinical trial data. This is an impact-focused role in a fast-growing science-driven company with a strong emphasis on collaboration and continuous improvement.
Arbeidsvoorwaarden / Benefits
- 401(k) match on first 6%
- health, dental, and vision insurance
- paid vacation, sick leave, holidays, parental leave
- backup care and family support programs
- tuition reimbursement
- Lifestyle Spending Account
Verantwoordelijkheden
- Develop and implement SDTM standards aligned with CDISC and industry guidelines
- Align SDTM with study eCRFs and external data collection standards; provide mapping guidance
- Act as SME for data standards, regulations, and processes
- Ensure SDTM datasets meet CDISC and regulatory submission requirements
- Support knowledge development on data standards, reporting, and tools
- Create quality control processes and metrics for standards compliance
- Ensure SOPs and regulatory guidance are followed; document standard processes and training
- Define standards specifications in collaboration with implementation teams
- Foster continuous process improvement and high-quality standards management
- Collaborate with Digital Solutions and IT to enable future strategies and tool adoption
- Serve as liaison between Clinical Programming and External Data Management to resolve data issues
Belangrijkste vereisten
- Bachelor’s degree in Statistics, Computer Science, or Life Sciences; 6–8 years in pharma/biotech/CRO or regulatory agency
- Proficient in SAS programming (6–8 years)
- Practical knowledge of R for clinical trials
- Knowledge of CDISC, FDA & ICH, GCP and regulatory requirements
- Experience managing multiple tasks and cross-functional teams to meet timelines
- Strong verbal and written communication in a matrix environment
- Experience in clinical data management/trial management with standards implementation (preferred)
- strong communication skills
- cross-functional collaboration
- attention to detail and precision
- SAS programming
- R
- CDISC SDTM standards
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