EDC Clinical Trial Designer – FSP

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✍️ Designer

🇬🇧 UK Skilled Worker Visa Sponsor

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IQVIA

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Create high quality data collection tools for new clinical trials • Facilitate the design, development, documentation, testing and implementation of clinical eCRF databases • Design eCRF forms using Oracle InForm/Central Designer or Veeva CDMS/Studio • Implement and utilize standard operating procedures, CRF Standards, process guidelines, and trial-specific guidelines • Understand detailed data collection requirements based on protocols and study team input • Work with libraries and create new forms when suitable forms do not exist • Produce annotated study books • Design workflows, dynamic forms, and events • Validate study designs for forms and schedule design • Develop test steps and perform quality control of forms • Provide input on data integrations, local lab management, and coding functionality • Provide input into post-production form changes to live trials • Apply lessons learned from one study build to the next • Conduct meetings with study teams to communicate work scope, project timelines, and project-specific requirements • Maintain working knowledge of regulatory requirements, industry trends, benchmarks, and best practices in data management and database design • Consistently meet timelines and deliverables while producing quality work products

🎯 Requirements

• BA/BS degree; commensurate experience will be considered • Minimum of 2 years of Clinical Data Management experience using electronic data capture systems • Proficiency with Central Designer/Studio • Familiarity with clinical research processes and CDISC/CDASH/SDTM standards • Experience designing eCRF forms using Oracle InForm/Central Designer or Veeva CDMS/Studio • Understanding of workflow design, dynamic forms, and events • Experience validating study designs for forms and schedule design • Experience developing test steps and performing QC of forms • Basic understanding of data integrations, local lab management, and coding functionality • Experience in planning and managing clinical trials in the biopharmaceutical industry or a related field • Effective oral and written presentation and communication skills • Strong attention to detail and commitment to high-quality work • Ability to manage multiple project tasks and deliverables in a fast-paced, constantly changing environment • This role is not eligible for UK visa sponsorship

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