Snr Clinical Database Designer

iqvia; Reading; Vor Ort; GBP 45.000 - 65.000; Vollzeit

Zusammenfassung

IQVIA in Reading, UK, is hiring a Technical Designer responsible for study build, design, and eCRF configurations within CDMS tools. You will ensure SDTM/CDASH alignment and create/Edit specification documents while coordinating with the DTL, programmers, validation, vendors, statisticians, and client representatives.

The role also covers project financials from the programming shared services perspective and may involve leading essential design meetings to drive successful study delivery.

Qualifikationen

• Bachelor’s degree in science/CS/IT or technology field.
• 2–4 years core Technical Designer experience; total experience 7+ years.
• Knowledge of SDTM/CDASH standards is expected.

Aufgaben

• Interpret the study protocol to design study components.
• Design and update the eCRF using CDMS tools in line with SDTM/CDASH standards.
• Create and update Edit Specification Documents.
• Generate specifications for EDC build components (e.g., rights and roles, system settings).
• Lead/participate in design review meetings and manage timelines and risks.
• Coordinate with DTL, programmer, validation team, vendors, statisticians, and client representatives.

Kenntnisse

Technical design experience

Total experience 7+ years

Ausbildung

Bachelor's Degree in Science/CS/IT or Technology

Jobbeschreibung

Reading, Berkshire, United Kingdom

Full time

R1571394

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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