8 часов назад
System Design Analyst II (Clinical Systems)
84 500 - 162 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
System Design Analyst II (Clinical Systems): Designing and delivering clinical trial systems, integrations, and study builds with an accent on EDC configuration, data standards, regulatory compliance, and cross-functional coordination. Focus on building Medidata RAVE studies, maintaining CDASH and SDTM alignment, solving delivery risks, and coaching design team members.
Location: Hybrid in North Chicago, Illinois, United States
Salary: $84,500–$162,000 per year
Company
develops innovative medicines and healthcare solutions across areas including immunology, oncology, neuroscience, and aesthetics.
What you will do
- Develop common data standards and ensure clinical system designs comply with protocol requirements.
- Design and deliver clinical trial systems, integrations, and changes across EDC, IRT, and ePRO platforms.
- Maintain team methodologies for clinical system design, functionality, user experience, and data flow.
- Track study progress, anticipate delivery or quality risks, and develop solutions to keep work on schedule.
- Coordinate with Clinical Data Organization and cross-functional stakeholders across upstream and downstream dependencies.
- Coach and mentor team members and lead innovation and process improvement initiatives.
Requirements
- Bachelor’s degree in business, management information systems, computer science, life sciences, or an equivalent field; a master’s degree is preferred.
- 5+ years of hands-on technical study build experience in EDC.
- Required experience with technical study builds in Medidata RAVE.
- In-depth knowledge of clinical trial processes and CDASH; knowledge of SDTM.
- Ability to influence without direct authority, communicate effectively, analyze problems, and coach or mentor in a matrixed environment.
- Knowledge of Good Clinical Practices, ICH Guidelines, applicable regulations, SOPs, and functional quality standards.
Nice to have
- Technical study build experience with Veeva EDC.
- Master’s degree.
Culture & Benefits
- Paid vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) benefits for eligible employees.
- Eligibility for short-term incentive programs.
- Work in a data science organization focused on clinical trial innovation and business value.
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