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Job Overview
Responsible 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).

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com