About IQVIA:

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. IQVIA creates intelligent connections to accelerate the development and commercialization of innovative medical treatments, helping improve patient outcomes and population health worldwide.

About the Role:

The Clinical Database Designer is responsible for designing clinical study databases and related specifications, ensuring timely and high-quality delivery of database components. This position collaborates closely with various project stakeholders to translate complex clinical study protocols into functional and reliable electronic data capture (EDC) systems.

Essential Functions:

• Interpret clinical study protocols to extract requirements for electronic data capture systems.
• Design and update electronic Case Report Forms (eCRFs) to accurately reflect study requirements.
• Create and maintain the Edit Specification Document, detailing logic checks, validations, and edit rules.
• Generate specifications for EDC system build components, such as user rights, roles, system settings, and home page configurations.
• Complete essential documentation including Study Authorization Forms and Trial Capacity Request Forms (specific to InForm EDC platform).
• Participate in key project meetings such as Pre-Design Meetings, Online Screen Review Meetings, and Unblinded Data Review Meetings, offering expert input and feedback.
• Attend and present during Internal Design Review Meetings, ensuring that all design aspects meet study requirements.
• Lead discussions in internal Edit Specification Review Meetings to finalize edit check definitions and logic.
• Design databases to collect specific data types, including LLRR (Last Live Read Review) data within the InForm platform, ensuring proper configuration of user rights and roles for secure data access and entry.

This role requires technical expertise, a solid understanding of clinical trials, attention to detail, and strong collaboration skills.

Key Technical Skills:

Clinical Data Management, eCRF Design, Edit Specification Documentation, InForm EDC, Database Design, Protocol Interpretation, User Rights and Roles Configuration, System Configuration, Clinical Trial Documentation

Requirements:

• Bachelor’s degree or higher in Life Sciences, Computer Science, Bioinformatics, or related field.
• Minimum of 2 years of experience in clinical database design or clinical data management, ideally with exposure to EDC systems such as InForm.
• Strong understanding of clinical trial protocols and their translation into EDC systems.
• Proficiency in creating eCRFs and developing edit checks and data validation rules.
• Experience with InForm EDC or similar clinical trial data platforms.
• Excellent communication and documentation skills, with the ability to collaborate effectively with multidisciplinary teams.
• Detail-oriented mindset with strong organizational and time-management skills.
• Ability to work in a hybrid environment, balancing remote and on-site responsibilities.