Clinical Database Developer

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts;
London, UK;
Leiden, Netherlands;
Basel, Switzerland;
Hyderabad, India and Shanghai, China. We are an affiliate of Honor Health, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/Rad Partners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

Under the direction of Imaging Operations Leadership, the Clinical Database Developer is primarily responsible for configuring and administrating Imaging Endpoints Clinical Trial Management System (iCTMS) and other clinical database systems as directed. This role will coordinate with the iCTMS vendor and iCTMS team members. The CDD will manage report development and system enhancements.

CLINICAL DATABASE DEVELOPER

RESPONSIBILITIES

- Collaborate with Project Management, Operations, and Data management to define system specifications, workflow, and documentation practices
- Lead project management activity related to the deployment of iCTMS, and other clinical database systems
- Analyze complex electronic case report form requests to determine feasibility for incorporation within clinical studies
- Support and/or lead data reporting activities by gathering user requirements, developing report specifications, and implementing both standardized and ad-hoc reports
- Engage with software vendors to understand their roadmaps and communicating functionality requirements of Imaging Endpoints
- Assist in user administration and operational support, including user and security management
- Assist in the creation of necessary training materials and SOPs related to clinical database systems
- Assist in the training of internal and external staff (when needed)
- Assist with the implementation and validation of a new imaging iCTMS as well as the migration of current studies to the new solution
- Assist in building, maintaining, and deploying study databases to collect clinical trial data, including custom system configurations and integrations
- Monitor and assist other iCTMS team members with the study build and new improvements
- Other duties as assigned by the manager

EDUCATION AND EXPERIENCE

- Bachelor’s degree in life sciences, computer science or equivalent work experience required
- Minimum of 3 years of experience developing data collection modules within EDC or other clinical database systems is required
- Knowledge and understanding of clinical development, FDA regulations, and Good Clinical
- Practices
- Proficiency in understanding software programming code, especially SQL dataset operations involving complex joins and record mergers

- Experience with relational data modeling techniques

- Experience with enterprise reporting applications preferred

Must have:

- 2–5 years’ hands‑on EDC build experience (Clindex preferred; Medidata Rave, Oracle InForm, Veeva, Medrio, Open Clinica accepted)
- Experience configuring CRFs/edit checks/visit schedules/user roles, practical test planning/UAT
- Basic SQL

Nice-to-have:

- Clindex experience and CDISC SDTM/data-standards mapping experience.

SKILLS

- Proficiency in MS Office and internet applications
- Service-oriented approach, flexible, and proactive toward adapting to client needs
- Ability to manage project activities with diverse group and individuals with little supervision
- Must have superior attention to detail including excellent oral and written communication skills.
- Must have the…