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Responsibilities
The EDC Clinical Trial Designer will create high quality data collection tools for new clinical trials and facilitate activities related to the design, development, documentation, testing and implementation of clinical eCRF databases. Design of eCRF forms using Oracle InForm/Central Designer or Veeva CDMS/Studio is expected. EDC Clinical Trial Designer will ensure that all relevant standard operating procedures, process and trial-specific guidelines are implemented and utilized to help ensure that a quality work product is produced and timelines and deliverables are consistently met.Summary of the Essential Functions of the JobProficiency with the following in Central Designer/StudioUnderstanding detailed data collection requirements based on the protocol and input from study team members.Working with libraries and creating new forms when suitable forms do not exist.Producing annotated study books.Basic understanding of workflow design, dynamic forms and events.Validation of study design for forms and schedule design.Test steps development and QC of forms.Basic understanding of activities needed for data integrations, local lab management, coding functionality.Input into design of post-production form changes to the live trials.Apply lessons learned from one study build to the nextAbility to conduct meetings with the study team to communicate work scope, project timelines, and project specific requirements.Maintain a good working knowledge relative to regulatory requirements, industry trends, benchmarks, and best working practices ticipating in relevant training and/or association activities.Minimum RequirementsBA/BS degree. Commensurate experience will be considered.Minimum of 2 years of Clinical Data Management experience using electronic data capture systems.Effective oral and written presentation and communication skills.Strong attention to detail and a commitment to high quality work, customer service and getting things right the first time with minimal errors.Ability to manage multiple project tasks and deliverables in a fast-paced constantly changing environment.Experience in the planning and management of clinical trials in the biopharmaceutical industry or a related field is preferred.Familiarity with clinical research processes and CDISC/CDASH/SDTM standards is preferred.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.Where you'll workHome-based: You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.CultureCulture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.
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