Snr Clinical Database Designer

IQVIA; Bloemfontein; Presencial; ZAR 600.000 - 900.000; Jornada completa

Descripción de la vacante

IQVIA in Bloemfontein, South Africa, seeks a Technical Designer to lead study build and design, and to edit specifications. You will collaborate with DTL, programmers, validation teams, vendors, statisticians, and client representatives.

Responsibilities include updating eCRF with CDMS tools aligned to SDTM/CDASH, creating Edit Specifications, and generating EDC build specifications. You will manage study design components and help with project timelines.

Formación

• Bachelor's Degree in Science/Computer Science/Information Technology or Technology
• 2–4 years of relevant core Technical designer experience and total exp being 7+ yrs.

Responsabilidades

• Interpret the study protocol and design/update the eCRF using CDMS tools in alignment with SDTM/CDASH.
• Create and update Edit Specification Document.
• Generate specifications for EDC build components (e.g., Rights and Roles, System Settings).
• Attend and lead design review meetings and facilitate internal Edit Specification discussions.
• Design the database to collect LLRR data within the InForm database and ensure appropriate access rights.
• Communicate project risks to Data Team Lead and escalate quality issues.
• Identify areas for process improvements and contribute to SOPs.

Conocimientos

Study design

SDTM/CDASH know-how

Stakeholder collaboration

Educación

Bachelor's Degree in Science/Computer Science/Information Technology or Technology

Herramientas

CDMS tools

eCRF design tools

InForm database

Descripción del empleo

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.

Essential Functions

• Interprets the study protocol.
• Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable.
• 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 the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting.
• Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document.
• Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates.
• 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 QIP 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.

Qualifications

• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
• 2-4 years of relevant core Technical designer experience and total exp being 7+ yrs. Req