Senior Technical Designer

Fortrea · Karnātaka, India

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Medical DeviceFull timeCompany career page

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Role summary

Fortrea seeks a Senior Technical Designer to lead electronic case report form (eCRF) design and specifications for clinical trial projects using major EDC platforms. The role involves managing study specifications, maintaining standards libraries, overseeing junior staff, and ensuring data quality and regulatory compliance.

What they're looking for

Bachelor's degree in life sciences, health sciences, information technology, or related field
Minimum 6 years relevant work experience in data management, database programming, or specification design
At least 4 years hands-on experience with Medidata Rave, Oracle Inform, Veeva Vault, or equivalent EDC systems
Demonstrated team leadership and staff mentoring capabilities
Excellent problem-solving skills and sound decision-making ability
Fluent in English, written and verbal
Knowledge of regulations pertaining to computerized systems and Good Clinical Practice

What you'll be doing

Design and review eCRF specifications, edit checks, and documentation within assigned EDC systems
Lead and mentor junior staff and programmers; oversee quality control of study specifications
Create, maintain, and ensure compliance of standard objects within global libraries
Collaborate with data managers and project teams on technical strategies and database design
Conduct team meetings, provide training on study build and standards, and participate in EDC system validation

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Date posted7 days ago

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