Snr Clinical Database Designer

IQVIA; Reading; Hybrid; GBP 55,000 - 75,000; Full time

Job summary

IQVIA LLC in Reading, Berkshire, United Kingdom, is seeking a Senior Clinical Database Designer to lead study build, design and configuration, collaborating with DTL, programmers, validation and client representatives.

The role emphasizes SDTM/CDASH alignment, creation of Edit Specifications, eCRF design, risk management and process improvement across multiple studies and platforms.

Qualifications

• Interprets the study protocol and aligns design with project goals.
• Design and update the eCRF using relevant CDMS tools per industry standards.
• Create and update Edit Specification Documents and build specifications.

Responsibilities

• Lead study design projects across platforms and manage timelines.
• Collaborate with DTL, programmers, validation, vendors, statisticians and clients.
• Ensure Rights and Roles, System Settings and Home Page specifications are accurate.
• Identify risks and drive quality improvements and process optimization.

Skills

Study design

Stakeholder communication

Leadership

Requirement analysis

Collaboration across teams

Education

Bachelor's degree in Science/Computer Science/Information Technology

Tools

SDTM

CDASH

eCRF tools/EDC

InForm database

Job description

## Snr Clinical Database DesignerApply: Reading, Berkshire, United Kingdom: Full time: Posted Today: 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