Clinical Programmer
***Please note: Only candidates with experience & background relevant to position requirements will be considered******
Overview
Ce3 is seeking an ambitious and accomplished Clinical Programmer candidates for an immediate opening. Specialized in the management of Phase 1 & 2 Oncology clinical trials, Ce3 has a strong, family-oriented culture focused on providing high quality services to our clients and professional growth to our employees. As a valued member of Ce3’s Data Operations group, our Clinical Programmers benefit from a competitive edge created by technology solutions, process efficiency, and collaborative relationships – join the team today!
Job Duties
- Setup clinical study databases in close cooperation with the EDC database developer and data manager
- Setup Data Management tools for study conduct (e.g. edit checks, validity tool, coding call, SAE etc.), and provide full study programming and validation support
- Develop programs for transforming acquisition data from the EDC/data entry system to the project standards (sponsor or CDISC), to include planning, construction, testing and maintenance of clinical databases in SAS or other DBMSs programs for assigned studies
- Ensure adherence to standards and validation of all study related calculations and data mappings
- Provide ongoing day to day end-user support to the data managers to ensure all systems and programs are executing correct and efficiently, to include validating/checking programming
- Develop, document, and test required programs/procedure data displays
- Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting
- Perform quality control on programs, to ensure output meets quality standards and project requirements, document and communicate findings to programmer
- Review draft case report forms and provide feedback to reduce inefficiencies in programming and database design
- Transfer CRF and analysis datasets, tables, listings and figures to clients in the requested format in a manner which communicates the content and issues of the deliverable
- Develop routine project specific applications to support the Company or other functional units (e.g. administrative tools) according to project requirements
- Maintain organized, complete and up-to-date study documentation, testing and validation/quality control documents and programs in compliance with company and sponsor standards
- Other duties & responsibilities as required by job function
Required Experience:
- The candidate has worked for a minimum of 5 years in the capacity of Clinical Programmer in a CRO or a bio-pharmaceutical company setting
- Ideal candidate will have 10 or more years of related experience and/or combination of experience and education/training
- The candidate can work productively in a partially or fully remote/WFH setting
- Demonstrated track record achieving aggressive timelines using creative problem-solving techniques
- Demonstrated ability to communicate with and motivate multiple partners/vendors/outsource partners
Required Knowledge & Technical Skills:
- MS/BA in a related discipline or significant equivalent education/training
- Proficiency with SAS programming and Medrio set up
- Exceptional verbal and written communication skills with high level of attention to detail
- Exceptional proficiency with appropriate programming software and/or certifications as required
- Proficiency with entire MS Office suite (Word, Excel, and Access) and MS Project preferred
Equal Employment Opportunity:
Ce3 is firmly committed to equal opportunity for all employees. We will not discriminate against employees or applicants for employment on any legally recognized basis including, but not limited to, veteran status and uniform service member status. In addition, race, sex, color, religion, national origin, age, marital status, pregnancy, child-bearing capacity, sterilization, fertility or related medical conditions; present or past physical or mental disabilities or disabilities when recruiting, hiring, training and promoting persons which are protected classes in Connecticut.