K3-Innovations, Inc. · 12 hours ago
Systems Designer / Analyst II
United States
Full-time
Remote
Mid, Senior Level
3+ years expK3-Innovations, Inc. is seeking a Systems Designer / Analyst II responsible for the design, delivery, and maintenance of Electronic Data Capture (EDC) systems that support clinical trials. The role involves translating study protocol requirements into EDC designs, optimizing functionality, and ensuring compliance with regulations.
Health CareMedicalMedical DevicePharmaceutical
Hiring Manager
Ilene Brooks
Responsibilities
Translating study protocol requirements into high-quality EDC designs, ensuring use of common data standards
Designing EDC systems to optimize functionality, end-user experience, and data flow
Owning the on-time design and delivery of new EDC systems, integrations (e.g., IRT), and required system changes
Utilizing project management tools to track progress, plan work, and proactively identify risks to timelines or quality
Ensuring therapeutic area (TA) and program-level consistency across studies
Collaborating with and influencing DSS and cross-functional stakeholders to meet study and program objectives
Synchronizing assigned deliverables with upstream and downstream dependencies
Ensuring compliance with federal and local regulations, GCP, ICH guidelines, SOPs, and functional quality standards
Staying current on evolving regulations, guidelines, and policies impacting clinical development
Participating in innovation and process improvement initiatives within DSS
Applying knowledge of CDASH and SDTM standards to support high-quality data collection
Demonstrating strong analytical, communication, and stakeholder-influencing skills, including influencing without direct authority
Qualification
Required
Medidata Rave Certification with 3+ years of study build experience
Strong communication and presentation skills
Ability to thrive in an ever-evolving environment; adaptable and comfortable with change
Bachelor's degree in business, management information systems, computer science, life sciences, or equivalent
3+ years of clinical technology (EDC) experience or 5+ years of experience in a similar technical or clinical development role
Strong understanding of the clinical trial process
Preferred
Master's degree
Experience with common industry design and development tools
Company
K3-Innovations, Inc.
K3-Innovations is redefining clinical research with a strategic scaling approach, blending AI-powered automation, adaptive clinical resourcing, and advanced data science.
51-200 employees
H1B Sponsorship
K3-Innovations, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (3)
2021 (3)
2020 (2)
Funding
Current Stage
Growth StageCompany data provided by crunchbase