Sr Clinical DB Designer

Iqvia Biotech; Bengaluru; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

IQVIA Biotech in Bengaluru seeks a Senior Technical Designer responsible for study build design, eCRF specification, and CDMS configuration. You will collaborate with DTL, Programmers, Validation, vendors, statisticians, and client representatives to ensure accurate study design components and aligned timelines.

You will also oversee project finances from the programming shared services perspective and lead design reviews, risk communication, and process improvements across multiple studies and

Qualifications

• Bachelor's degree in a relevant field (Science/CS/IT or BT) is required.
• 7+ years of core technical designer experience.
• Hands-on experience with eCRF/CDMS tools and SDTM/CDASH standards.

Responsibilities

• Interprets the study protocol.
• Designs and updates the eCRF using CDMS tools in line with SDTM/CDASH.
• Creates and updates Edit Specification Documents.
• Generates specifications for EDC build components (Rights and Roles, System Settings).
• Completes Study Authorization Form and Trial Capacity Request Form (InForm).
• Leads and participates in design reviews and internal meetings; may lead Online Screen Review Meeting.

Skills

Technical design

SDTM

CDASH

Education

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

Job description

Job Summary

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.

Responsibilities

• 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

• Bachelors Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
• 7+ years of relevant core Technical designer experience