Note: The job is a remote job and is open to candidates in USA. K3 Innovations is seeking an experienced EDC Systems Designer / Analyst III to support a leading global biopharmaceutical organization's Clinical Data Strategy Organization. The role focuses on designing and delivering clinical trial systems, leading Medidata RAVE study builds, ensuring regulatory and data standards compliance, and collaborating with cross-functional teams to improve clinical data quality and efficiency.
Responsibilities
- Design, develop, and deliver clinical trial systems, including EDC, IRT, and ePRO, ensuring compliance with protocol requirements and enterprise data standards
- Lead technical study builds in Medidata RAVE and ensure consistency across therapeutic area and program-level initiatives
- Develop and maintain clinical systems design methodologies aligned with industry best practices and regulatory standards
- Collaborate with Clinical Data Operations and cross-functional stakeholders to support study timelines, integrations, and system enhancements
- Utilize project management tools to monitor progress, identify risks, and proactively resolve issues impacting quality or timelines
- Ensure compliance with GCP, ICH Guidelines, FDA regulations, SOPs, and quality standards
- Mentor and coach team members while promoting knowledge sharing and technical excellence
- Lead innovation and continuous process improvement initiatives within the Clinical Data Strategy Organization
Skills
- Bachelor's degree in Computer Science, Information Systems, Life Sciences, Business , or a related field
- 7+ years of hands-on experience with technical study build in EDC systems
- Required: Extensive experience building clinical studies in Medidata RAVE
- Strong understanding of CDASH (required) and SDTM standards
- Deep knowledge of clinical trial processes and clinical data management best practices
- Strong analytical, communication, and problem-solving skills
- Proven ability to influence cross-functional teams and mentor colleagues in a matrixed environment
- Technical study build experience with Veeva EDC
- Experience supporting enterprise clinical data strategy initiatives
- Expertise in clinical systems integration and process optimization
- Experience leading cross-functional innovation and standardization projects
Benefits
- Remote work arrangement (preference for candidates in New Jersey or near Chicago, IL or Irvine, CA office)
- 1-year contract with a strong likelihood of extension into a second year
- Opportunity to work with one of the world's leading biopharmaceutical organizations on cutting-edge clinical development programs
- Opportunity to play a key role in advancing enterprise clinical data standards and technology innovation
- Collaboration with global, multidisciplinary teams driving digital transformation in clinical research
Company Overview
Company H1B Sponsorship