EDC Clinical Trial Designer – FSP

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Develop high-quality tools for data collection in new clinical trials.

• Oversee the design, development, documentation, testing, and implementation of clinical eCRF databases.

• Create eCRF forms utilizing Oracle InForm/Central Designer or Veeva CDMS/Studio.

• Implement and adhere to standard operating procedures, CRF Standards, process guidelines, and trial-specific protocols.

• Comprehend detailed data collection demands based on study protocols and team input.

• Collaborate with libraries and generate new forms when appropriate forms are unavailable.

• Produce annotated study books.

• Design workflows, dynamic forms, and events.

• Validate study designs for forms and scheduling.

• Develop test steps and conduct quality control on forms.

• Offer insights on data integrations, local lab management, and coding functionalities.

• Contribute to post-production form modifications for ongoing trials.

• Leverage insights gained from one study build to improve subsequent projects.

• Hold meetings with study teams to convey work scope, project timelines, and specific requirements.

• Keep an up-to-date understanding of regulatory requirements, industry trends, benchmarks, and best practices in data management and database design.

• Consistently achieve timelines and deliverables while ensuring high-quality outputs.

⛳️ Requirements

• BA/BS degree; relevant experience will be taken into account.

• At least 2 years of experience in Clinical Data Management utilizing electronic data capture systems.

• Expertise in Central Designer/Studio.

• Familiarity with clinical research procedures and CDISC/CDASH/SDTM standards.

• Experience in designing eCRF forms with Oracle InForm/Central Designer or Veeva CDMS/Studio.

• Knowledge of workflow design, dynamic forms, and events.

• Experience in validating study designs for forms and scheduling.

• Background in developing test steps and conducting quality control on forms.

• Basic understanding of data integrations, local lab management, and coding functionalities.

• Experience in planning and managing clinical trials within the biopharmaceutical sector or a related field.

• Strong oral and written communication and presentation skills.

• Exceptional attention to detail and a commitment to producing high-quality work.

• Ability to juggle multiple project tasks and deliverables in a dynamic, fast-paced environment.

• Please note that this position is not eligible for UK visa sponsorship.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Opportunities for professional development and growth.

• Flexible work hours and remote work options.

• Supportive team environment with a focus on collaboration.