EDC Clinical Trial Designer

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

About the role

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. The role ensures that all relevant standard operating procedures, Incyte CRF Standards, process, and trial-specific guidelines are implemented and utilized to produce a quality work product while meeting timelines and deliverables.

Responsibilities

• Proficiency with Central Designer/Studio.
• Understand detailed data collection requirements based on the protocol and input from study team members.
• Work with libraries and create new forms when suitable forms do not exist.
• Produce annotated study books.
• Basic understanding of workflow design, dynamic forms, and events.
• Validate study design for forms and schedule design.
• Develop test steps and perform QC of forms.
• Basic understanding of activities needed for data integrations, local lab management, and coding functionality.
• Contribute to the design of post-production form changes for live trials.
• Apply lessons learned from one study build to the next.
• Conduct meetings with the study team to communicate work scope, project timelines, and project-specific requirements.
• Maintain a good working knowledge of regulatory requirements, industry trends, benchmarks, and best practices in data management and database design through reading, training, and association activities.

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 accuracy with minimal errors.
• Ability to manage multiple project tasks and deliverables in a fast-paced, constantly changing environment.

Qualifications

• 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.

Work Environment

ProPharma supports remote working but encourages hybrid work for new hires based within a reasonable commute of one of our offices to facilitate in-person collaboration. All applications are reviewed personally by our recruitment team, and candidates are evaluated based on merit, not proximity to an office.