Description
We are seeking a Technical Designer to join our team. As a Technical Designer, you will be responsible for study build and design, editing specifications, system configurations, and associated study design components. You will collaborate with various stakeholders, including DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, you will also be responsible for project financials from a programming shared services perspective.
Key Responsibilities:
- Interpret the study protocol
- Design and update eCRFs using third-party or in-house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable
- Create and update Edit Specification Documents
- Generate specifications for EDC build components
- Complete Study Authorization Forms and Trial Capacity Request Forms
- Attend meetings, including Pre-Design Meetings, Online Screen Review Meetings, and Unblinded Data Review Meetings
- Facilitate internal Edit Specification Review Meetings and lead discussions regarding Edit Specification Documents
- Design databases to collect LLRR data and ensure Rights and Roles documents have appropriate access
- Communicate project risks to the Data Team Lead
- Escalate potential quality issues
- Ensure completion and documentation of project-specific training and stay current with required Standard Operating Procedures
- Review build timelines and provide input as applicable
- Identify areas for process improvements and contribute to process improvement initiatives
Requirements:
- Bachelor's degree in Science, Computer Science, Information Technology, or Technology
- 2-4 years of relevant core Technical Designer experience and 7+ years of total experience