Snr Clinical Database Designer

IQVIA; Bellville; On-site; ZAR 1,404,000 - 1,716,000; Full time

Job summary

IQVIA in South Africa seeks a Technical Designer to drive study build and eCRF design, ensuring alignment with SDTM/CDASH standards. You will collaborate with DTL, programmers, validation, vendors, statisticians, and client representatives to deliver projects and oversee programming-related financials.

The role involves designing the InForm-based database, creating edit specifications, and producing EDC component specs while leading internal design reviews and promoting continuous process

Qualifications

• Interprets the study protocol and translates it into SDTM/CDASH-compliant eCRF design.
• Design and update eCRF using CDMS tools per industry standards.
• Create and update Edit Specification Document for study components.
• Generate specifications for EDC build components such as Rights/Roles and System Settings.

Responsibilities

• Lead and participate in design review meetings and present comments.
• Design database to collect LLRR data and manage access rights.
• Ensure project timelines and communicate risks to Data Team Lead.

Skills

eCRF design

CDMS tools

SDTM

CDASH

Education

Bachelor's degree in Science/CS/IT

Tools

InForm

Job description

Bloemfontein, South Africa

Bellville, South Africa

Centurion, South Africa

Full time

R1559093

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

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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