Snr Clinical Database Designer

IQVIA; Bellville; On-site; ZAR 400 000 - 600 000; Full time

Job summary

A global leader in clinical research services is seeking a Technical Designer in Bellville, Western Cape, to manage study builds, designs, and project financials. The ideal candidate will have a Bachelor's degree and 2–4 years of relevant technical design experience but should possess a total of 7 or more years. Strong collaboration skills and the ability to identify process improvements are crucial for this role.

Qualifications

• 2-4 years of relevant core Technical designer experience.
• 7+ years of total relevant experience.

Responsibilities

• Interprets the study protocol and designs eCRF.
• Generates specifications for EDC build components.
• Communicates project risks and escalates quality issues.

Skills

Study protocol interpretation

Database design

Project financial management

Stakeholder collaboration

Education

Bachelor in Science/Computer Science/Information Technology or Bachelor in Technology

Job description

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 lead 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 experience of 7+ years (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