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 HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), 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, OpenClinica 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 ability to work independently, multitask, and meet critical timelines under pressure
• Must have strong time management and organization skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Ability to work in strict compliance with all procedures, rules, and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Ability to prioritize workload to the changing needs of the day-to-day business
• Ability to understand technical research protocols and successfully lead within the research environment

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints https://caringendpoints.org/
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE everyday
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: Up to 5% (domestic and/or international)