Clinical Trial Technology Expert

About the RoleThis is a dynamic and innovative opportunity for an expert in clinical trial technology to join our team. We are seeking a talented Veeva EDC Programmer who can drive clinical trials forward with cutting-edge solutions.As a key member of our team, you will be responsible for creating eCRF specifications, designing, developing, and validating clinical trial setup processes. You will also create edit check specifications, set up edit checks at trial level, implement UAT scripts, and manage blinded and unblinded study configurations.In this role, you will work closely with data engineers and data management programmers on study-level integrations and deliveries. You will lead technology vendor oversight activities and partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.We are looking for someone with strong technical skills, excellent problem-solving abilities, and excellent communication skills. If you have experience in clinical trial technology and a passion for innovation, we would love to hear from you.Key ResponsibilitiesCreate eCRF specifications, design, develop, and validate clinical trial setup processesCreate edit check specifications and set up edit checks at trial levelImplement UAT scripts to test the setup of the clinical studySet up different instances of study URL (e.g., UAT, production, testing etc.)Set up and configure user accounts for study teamsSet up and manage blinded and unblinded study configurationsBe the SME for all EDC database related activitiesSet up, configure, validate, and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.Understand when custom functions are required within EDC systemsAbility to troubleshoot database setup as per study needsPrepare, test, and implement post-production changes as per study needsPartner with appropriate team members to establish technology standards and governance modelsOversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizationsBe a primary change agent to ensure adoption of new capabilities and business processesBe the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of qualityWork with leaders to resolve issues affecting the delivery of clinical trialsWork closely with data engineers and data management programmers on study-level integrations and deliveriesLead technology vendor oversight activitiesPartner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risksConfirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documentsParticipate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or auditTrack study deliverables and evaluate study metrics to mitigate risk for major data management deliverablesAdaptable to new ways of working using technology to accelerate clinical trial setupRequirementsTo be successful in this role, you will need:Bachelor's degree in Computer Science, Information Technology, or related fieldMinimum 5 years' experience in clinical trial technologyStrong knowledge of Veeva EDCExcellent problem-solving and analytical skillsExcellent communication and interpersonal skillsAbility to work independently and as part of a teamWhat We OfferWe offer a competitive salary and benefits package, including:Health insuranceDental insuranceVision insuranceRetirement planFlexible work arrangementsOngoing training and development opportunitiesHow to ApplyIf you are a motivated and experienced clinical trial technology professional looking for a new challenge, please submit your application.