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Principal Technical Designer Analyst job in San Mateo at IQVIA

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Principal Technical Designer Analyst at IQVIA

Principal Technical Designer Analyst

IQVIA San Mateo, CA Full-Time
Job Overview

The Prinicpal Technical Designer Analyst will be responsible to oversee delivery and build of multiple studies in multiple platforms. A person in this role should 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.

Essential Functions

+ 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.Â

+ 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 inputsÂ

+ 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

+ May contribute/assist Manager in resource planning for TD projects

+ Act as an SME for TD role

+ Particpants in vendor solutions management as required

+ Completes post Go Live and post Mid Study Updates (MSU) quality checks and monthly quality checks

+ 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. '

Qualifications

+ Bachelor's Degree clinical, biological or mathematical sciences, or related field or nursing qualification

+ 5 years relevant experience including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials >1000 patients, and including experience handling customer negotiations (e.g. bid defense meetings). Equivalent combination of education, training and experience.

+ Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology.

+ Knowledge of operating procedures and work instructions and the ability to apply them in practice.

+ Excellent experience and organizational, communication, and demonstrated expert data management skills.

+ Comprehensive understanding of clinical drug development process (detail oriented).

+ Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at [ Link removed ] - Click here to apply to Principal Technical Designer Analyst

EEO Minorities/Females/Protected Veterans/Disabled

Recommended Skills

  • Attention To Detail
  • Biology
  • Clinical Works
  • Coaching And Mentoring
  • Communication
  • Data Management
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