EDC Clinical Trial Designer (Clinical Data Management)

Location: United States; remote work is supported, with hybrid collaboration encouraged for new hires located within a reasonably short commute of a hirify.global office.

Company

hirify.global provides regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology consulting solutions for biotech, medical device, and pharmaceutical organizations.

What you will do

• Design high-quality electronic case report forms and data collection tools for new clinical trials.
• Translate protocol and study-team data collection requirements into eCRF forms, schedules, workflows, and dynamic forms.
• Use libraries and create new forms in Oracle InForm/Central Designer or Veeva CDMS/Studio.
• Produce annotated study books and validate form and schedule designs.
• Develop test steps, perform quality control, and support implementation and post-production form changes.
• Coordinate with study teams on scope, timelines, requirements, regulatory practices, and clinical data standards.

Requirements

• BA/BS degree or equivalent experience.
• At least 2 years of clinical data management experience using electronic data capture systems.
• Experience with Oracle InForm/Central Designer or Veeva CDMS/Studio.
• Strong oral and written communication, presentation, attention to detail, and quality focus.
• Ability to manage multiple project tasks and deliverables in a fast-paced, changing environment.
• Familiarity with clinical research processes and CDISC, CDASH, and SDTM standards is preferred.

Nice to have

• Experience planning and managing clinical trials in the biopharmaceutical industry or a related field.
• Knowledge of data integrations, local laboratory management, and coding functionality.

Culture & Benefits

• Remote working is supported, with in-person collaboration available through a hybrid arrangement where agreed with the manager.
• Inclusive, diverse, and equal-opportunity workplace.
• Environment supporting innovative, collaborative, and entrepreneurial work.
• Applications are personally reviewed by the recruitment team without AI screening tools.

Hiring process

• Applications are reviewed personally by a member of the recruitment team.
• Applicants receive an outcome regarding their application.