Junior/Senior Clinical Database Designer

Job OverviewResponsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective.

Qualifications

• 대리~차장급 • Minimum 2-3 years of relevant working experience including at least 1 year of EDC Build-up • Thorough knowledge of data management process and skills• Full DM life-cycle study management 경력자 우대• SAS, SQL등을 이용한 data 관리 경력자 우대• CDISC SDTM 생성 및 검증 경력자 우대

Essential Functions

• Interprets the study protocol.

• Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards.

• Create and update Edit Specification Document.

• Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page)

• Complete the Study Authorization Form and Trial Capacity Request Form (InForm)

• Attend and present comments at the Internal Design Review Meeting. 

• Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document.

• Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan.

• Escalate potential quality issues.

• Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures.

• Reviews build timelines and provide input as applicable.

• Reviews budget tool for own projects, identify out of scope activities if any and inform relevant parties.

• Responsible for multiple study design projects at the same time.

• Might be working on projects across multiple platforms.

• Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes.

• All responsibilities are essential job functions unless noted as nonessential (N).