EDC Clinical Trial Designer: Build & Validate eCRF Forms

IQVIA LLC; Durham (NC); On-site; USD 69,000 - 171,000; Full time

Job summary

IQVIA is seeking an EDC Clinical Trial Designer to create high quality data collection tools for new clinical trials and to facilitate design, development, documentation, testing and implementation of clinical eCRF databases. Form design using Oracle InForm/Central Designer or Veeva CDMS/Studio is expected.

The role emphasizes meeting timelines, applying SOPs, and collaborating with study teams to ensure quality and regulatory alignment, with focus on data management, trial design, and

Qualifications

• BA/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.

Responsibilities

• Proficiency with the following in Central Designer/Studio
• Understanding 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 next.
• Ability 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 in data management and database design by reading, participating in relevant training and/or association activities.

Skills

Oral communication

Written communication

Attention to detail

Project management

Clinical data management

Education

BA/BS degree

Tools

Central Designer/Studio

Oracle InForm/Central Designer

Veeva CDMS/Studio

Job description

IQVIA is seeking an EDC Clinical Trial Designer to create high quality data collection tools for new clinical trials and to facilitate design, development, documentation, testing and implementation of clinical eCRF databases. Form design using Oracle InForm/Central Designer or Veeva CDMS/Studio is expected.

The role emphasizes meeting timelines, applying SOPs, and collaborating with study teams to ensure quality and regulatory alignment, with focus on data management, trial design, and