Description
We are seeking a Study Design and Implementation Lead to be responsible for study build and design, edit specifications, system configurations and associated study design components. This role involves collaboration with various stakeholders including DTL, programmers, validation teams, vendors, statisticians and client representatives.
Key Responsibilities:
- Interpret study protocols
- Design and update electronic Case Report Forms (eCRFs) using CDMS tools
- Create and update edit specification documents
- Generate specifications for EDC build components
- Participate in pre-design meetings, online screen reviews and unblinded data reviews
- Facilitate internal edit specification review meetings
- Communicate project risks to the Data Team Lead
- Escalate potential quality issues
- Ensure completion and documentation of project-specific training
- Review build timelines and provide input
- Manage multiple study design projects simultaneously
- Identify areas for process improvements
Requirements:
- Bachelor's degree in Science, Computer Science, Information Technology or Technology
- 2-4 years of relevant experience in technical design and 7 years of total experience
- Experience with Medidata RAVE and other CDMS tools
Benefits:
- Competitive salary range: $86,700.00 - $115,605.36 per year
- Comprehensive benefits package including health and wellness programs