Principal Clinical Programmer

Serve as the lead Clinical Programmer to build or manage the build of validated clinical databases following CTI SOPs, programs validation procedures using Medidata Rave, Anju’s TrialMaster, or other database application. The Principal Clinical Programmer will help develop best practices and mentor/train the Clinical Programming staff. The Principal Clinical Programmer will also provide leadership and guidance to the Clinical Programming staff regarding build and maintenance of validated clinical databases and electronic edit checks. 

ESSENTIAL FUNCTIONS

• 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.  

REQUIRED EDUCATION AND EXPERIENCE

• 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


• Extensive experience in Electronic Data Capture systems (e.g., Medidata Rave, Anju’s TrialMaster, etc.) -preferred