Clinical DB Designer

Iqvia Biotech

Bengaluru, Cochin / Kochi / Ernakulam

5-8 Years

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Job Description

Interprets the study protocol.
Design and update the eCRF.
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.
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.
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

More Info

Job Type:

Permanent Job

Industry:

Biotechnology

Role:

Data Management /Statistics

Function:

Pharmaceutical/Biotechnology

Employment Type:

Full time

Open to candidates from:

Indian

About Company

Iqvia Biotech

IQVIA Biotech is a biotech-specialized CRO delivering flexible clinical development solutions for biotech and emerging biopharma companies. Our clinical solutions are built on 25 years of unmatched experience with therapeutically aligned expertise, uniquely designed to deliver full-service solutions on a global scale.

Job ID: 120003283

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