Senior Technical Designer Analyst

The Sr Technical Designer Analyst will be responsible to oversee delivery and build of multiple studies in multiple platforms. A person in this roleshould have understanding of budget and finances for start up phase and will look into QIP/project finance for TD activities for all studies under purview. This role will work with the DTL, Validation Team Lead and Functional Managers. They may also communicate with sponsor as required. The Sr Technical Designer Analyst will be involved in library creation and must be an expert in at least 2 therapeutic areas.

Oversees timely delivery of study deliverables with quality

Interprets the study protocol

Designs and updates the eCRF

Creates and updates the Edit Specifications document

Generates specifications for EDC build components (e.g.,System Settings)

Attends the eCRF Design Specification Meeting, Attends the Internal Design Review Meeting and Online Screen Review Meeting and supports DTL as needed.
May present at the Online Screen Review Meeting a visual design walk through.

Facilitates the Internal Edit Check Specification Review Meeting and leads the discussions regarding the Edit Specifications document

Designs the database to collect Local Lab Reference Ranges (LLRR) data within the IBM Clinical Development or applicable database platform and ensures access Rights and Roles has appropriate access for Entry and Updates

Identifies and escalates potential Quality Issues to relevant parties with suggested solutions

Ensures the completion and documentation of all project-specific training, as well as staying current with required SOP reading for self and other TDs within the team

Reviews build timelines and provides inputs

Reviews QIP/ POP for own projects, identify out of scope activities if any and inform relevant parties

Communicates any project risks to the DTL, including any risk for missing a timeline in the Data Management Project Plan (MS Project)

Designs Library Source Study and Creates Edit specifications for source study

Support other TDs in studies based on their therapeutic area expertise

Mentors and trains new TDs in the team

Oversee budget and financial performance of multiple TD studies within scope and inform relevant parties as required

Act as an SME for TD role

Identifies areas for process improvements continuously. Proactively take part and contribute towards process improvement initiatives besides providing suggestions/ideas for continuous improvement of the process.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.