Descrição
Clinical Programmer I
Job Purpose/Summary
Build custom databases in support of clinical studies in different areas of data collection.
What You’ll Do
- Create database entry screens based on approved case report form (CRF) casebook
- Perform internal testing of entry screens prior to user acceptance testing
- Work with Study Clinical Data Manager to implement system edits on built entry screens
- Program validation procedures, for clinical studies and other billable projects. Validation procedures are programming code that output edit failures in CTI systems when checking the data against expected values. These expected values could be acceptable ranges or form flow edits/visit progression.
- Maintain necessary study build documentation as required by Clinart SOPs
- Meet all project deadlines on time and on budget
- Ensure accuracy of clinical databases as compared to the CRF; perform user acceptance testing (UAT) of database and provide feedback to study team regarding any discrepancies
- Perform UAT on programmed edits in clinical database; ensure accuracy of edits in database as compared to edit specifications documents; provide feedback to study team on functioning of edits. The CP I performs UAT is comprehensive and at their own direction. The programmers are to test the forms they have built as well as any edits or derivations that they have programmed.
- Perform review and issue queries for CRF data, based on automated edit checks, manual review, post-hoc data listings, and sponsor requirements
- Maintain all necessary data review documentation to support accurate data cleaning
- Participate in data management system selection processes as requested
- Provide input into development and revisions of CDM department SOPs
What You Bring
- Good knowledge in Database technologies such as Java, Javascript, SQL, and Microsoft Access
- Working knowledge of enterprise-level relational databases
- Analytical, detail oriented
- Ability to analyze complex data issues and make recommendations for solutions
- Knowledge of drug development and clinical research process
- Ability to communicate effectively both orally and in writing
- Ability to work independently and be self-motivated
- Excellent problem solving skills
- Bachelor’s degree, technical degree in IT / Computer Science and/or medical scientific background, or equivalent experience
- 1-2 years of experience in clinical research field or working with databases in complex environment
- Fluent in English
Why CTI?
At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.
For that reason, we treat our team members with the respect they deserve, and our numbers show it:
- We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
- We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
- Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
- We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
- We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
- Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
CTI Clinical Trial and Consulting Services
Filipa Magalhães