Clinical Trial Designer

Creative Solutions Services, LLC; Wilmington (DE); On-site; USD 85,000 - 120,000; Full time

Job summary

Kaztronix is seeking an EDC Clinical Trial Designer to create high quality data collection tools for new clinical trials. You will design eCRF forms using Central Designer/Studio or Veeva CDMS/Studio and ensure SOPs and standards are applied to deliver accurate, timely results.

You will lead form design activities, validate study designs, and collaborate with the study team to meet timelines. Strong communication, attention to detail, and familiarity with CDISC/CDASH/SDTM are preferred.

Qualifications

• BA/BS degree or commensurate experience.
• 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.
• Ability to manage multiple project tasks in a fast-paced environment.
• Experience in planning and management of clinical trials in biopharmaceuticals or related field preferred.
• Familiarity with CDISC/CDASH/SDTM standards preferred.

Responsibilities

• Design and build eCRF forms using Central Designer/Studio and Veeva CDMS/Studio.
• Create annotated study books and validate study design for forms and schedules.
• Develop test steps and perform QC of forms.
• Provide input on post-production form changes for live trials.
• Communicate work scope, timelines, and requirements with the study team.
• Maintain regulatory knowledge and adopt best practices in data management and database design.

Skills

Clinical Data Management

Effective communication

Attention to detail

Project multitasking

Regulatory knowledge

Education

BA/BS degree

Tools

Central Designer/Studio

Veeva CDMS/Studio

Job description

Job Summary

The EDC Clinical Trial Designer will create high quality data collection tools for new clinical trials and facilitate activities related to the design, development, documentation, testing and implementation of clinical eCRF databases. Design of eCRF forms using Oracle InForm/Central Designer or Veeva CDMS/Studio is expected. In addition, the EDC Clinical Trial Designer will ensure that all relevant standard operating procedures, CRF Standards, process and trial-specific guidelines are implemented and utilized to help ensure that a quality work product is produced and timelines and deliverables are consistently met.

Summary of the Essential Functions of the Job

• 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.

Minimum Requirements

• 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.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.