CTI Clinical Trial and Consulting Services · 20 hours ago
Principal Clinical Programmer
United States
Full-time
Remote
Senior Level, Lead/Staff
6+ years expCTI Clinical Trial and Consulting Services is seeking a Principal Clinical Programmer to lead the build and management of validated clinical databases. This role involves mentoring Clinical Programming staff, providing leadership, and ensuring compliance with CTI SOPs while overseeing the database architecture for clinical trials.
BiotechnologyConsultingPharmaceutical
Responsibilities
Act as the primary lead database architect for Sponsor clinical databases using Medidata Rave, Anju’s TrialMaster, or other database applications as needed for Clinical Trials
Create or direct creation of database entry screens based on approved case report form (CRF) casebook
Perform or direct internal testing of entry screens prior to user acceptance testing
Work with Study Clinical Data Manager to implement system edits on built entry screens
Develop or direct development of validation procedures, as needed, for clinical studies and other billable projects
May aid in the maintenance and development of selected in-house CTI systems related to Data Management
Participate in data management system selection processes as requested
Provide input into development and revisions of CDM department SOPs
Maintain necessary documentation as required by CTI SOPs
Meet all project deadlines on time
Collaborate with data management and study managers on CRF design
Manage clinical study database build process from start to finish
Provides leadership, training, mentorship, and support to other Clinical Programmers
As required, oversees clinical programming operations by providing supervision for a team of Clinical Programmers. Responsibilities may include advising junior staff and professional development
Assigns routine programming tasks, guiding and reviewing work, and evaluating performance
Provide quality control pertaining to programming output and data files, including those produced by supervised staff
Analyzes complex specifications, formulates programming approaches, and consults with internal and external clients to clarify requirements and improve processes
Maintains a broad overall knowledge in the field of clinical programming and clinical data management through continued education by attending training classes, reading related literature, attending professional meetings, etc
Qualification
Required
6+ years of experience working with clinical databases in a complex CDM environment
Knowledge of clinical research and operations, and prior data management experience
Bachelor's degree or equivalent experience in Computer Science/Information Technology or a technical degree in a related field
Preferred
Extensive experience in Electronic Data Capture systems (e.g., Medidata Rave, Anju's TrialMaster, etc.)
Company
CTI Clinical Trial and Consulting Services
CTI is a full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services.
1001-5000 employees
H1B Sponsorship
CTI Clinical Trial and Consulting Services 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
2023 (1)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Timothy Schroeder
Chairman & CEO | Founder
Recent News
Medidata Solutions, Inc.
2025-11-04
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