EDC Clinical Trial Designer

Summary

IQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. The EDC Clinical Trial Designer will create and validate electronic clinical trial data collection tools, design eCRF databases, and support their documentation, testing, and implementation. The role also involves coordinating with study teams, managing deliverables, and ensuring compliance with applicable procedures and standards.

Responsibilities

• 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

• * 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

Qualifications

Must Haves

• * 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

Nice to Haves

• * 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

Benefits

• Remote work arrangement.
• Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.