Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus’ proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
Summary:
Responsible for delivering quality EDC trial configurations for sponsor leveraging the needed Electronic Data Capture (EDC) platform. You will perform configuration for those EDC projects and building those studies in the needed EDC platform. In addition, as the Database Programmer you will perform Quality
Control of configured projects for activities that you did not perform the development/configuration. You will also provide consulting services that may include user acceptance testing (UAT) of EDC systems, global library/standards development, and report quality control.
Job Responsibilities:
Assists with database design or modifications to solve database processing problems considering computer equipment capacity and limitations, operating time, and form of desired resultsPerforms the administration, monitoring, tuning and support of databases in the production environmentSupport Lab Administration and Coder Module within MedidataDesign specifications of EDC Trial Build services for core configuration, eCRFs, data validations (DVS) and reportingDevelop configuration of the EDC trial by utilizing the trial design specifications for eCRFs, DVS, custom functions integrations and reportingAdvise clients on best practices for clinical database builds, eCRF layout and compliance with CDISC/CDASH standardsImplement and perform data integrations related activities to ensure data integrations meet client requirementsCollaborate with the project team to ensure data can be extracted easily from the back end to support efficient downstream reporting and analysisCollaborate with the project team to ensure the configuration is completed on time with high qualityProvide Quality Control on deliverables developed by other team membersMaintain all required Configuration Specifications and Quality Control documents as required by SOP and ProcessesCollaborate with training team as an EDC Subject Matter Expert and perform trainingWork on consulting efforts related to EDC systems including UAT, global library/standards developmentEnsure compliance with industry quality standards, regulations, guidelines, and proceduresImplements database setups of development, user acceptance test and production environmentsImplements backups and recovery proceduresMay participate in database analysis and database design tasks to meet required operational standards and performance levels (as measured by reliability, response time, query execution time, etc.)May participate in database consultations and database design reviewsDevelop and maintain good communications and working relationships with teams and external clientsConducts review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documentsWork collaboratively with other departments to optimize cross department functionalityEstablish and maintain positive relationships with industry clients that foster confidence and facilitate problem resolutionMay participate in or lead departmental or corporate initiativesPerforms other work-related duties as assignedMinimal travel may be required
Demonstration of Tempus Compass Values:
Consistently strives to demonstrate the following Tempus Compass values:
Recognizes that the team is always stronger than the individualSeeks to inspire others by demonstrating consistently strong performanceTreats people with respect regardless of role or point of view Listens well and seek to understand before reactingProvides candid, helpful, and timely feedback to colleaguesDemonstrates curiosity about and contributes effectively to areas outside of their specialtyKeeps the bigger picture in mind when making decisionsNever stops learningQuestions assumptions and offers suggestions for improvementFocuses on results rather than process and seeks to minimize complexity when process is requiredIdentifies and addresses root causes, not symptomsDemonstrates poise in stressful situationsStrives to always do the right thingQuestions actions that are incongruent with Tempus Compass values
Minimum Qualifications:
Bachelorâs degree preferred, analytic discipline a plus (Computer Science or Health related field) and/or equivalent work experience7+ years in CRO/Pharmaceutical/Biotechnology industryExperience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languagesKnowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and CDISC standards (CDASH, SDTM)Medidata RAVE Certified and 5+ yearsâ experience working with Medidata Rave platformOncology clinical trials or oncology clinical experienceExcellent written and verbal communication skillsExcellent organizational skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelinesAble to proactively anticipate needs and follow through on all assigned tasksProficient in Microsoft Word and Excel
Preferred Qualifications:
Custom Functions programming experience using C#Familiarity with EDC Systems: Medrio and REDcapExperience with Business Intelligence Tools: Business Objects, JReview, BOXI, or relatedEarly phase clinical trial experience