Principal Database Programmer

This is a fully remote position, open to applicants in Slovakia.

📋 Description

• Oversee all programming elements of clinical databases and applications from the initiation of studies through to post database lock.

• Direct operational study teams and programming staff on designated studies and study programs.

• Deliver operational and technical training to end users, junior personnel, and data management project teams.

• Provide planning estimates encompassing project scope, schedules, forecasting, and resource needs.

• Manage assigned projects to guarantee timely delivery.

• Update internal teams and study teams on project status and contract/scope changes.

• Anticipate project hours, determine resource needs, and oversee project budgets, out-of-scope work, and post-production modifications.

• Offer insights and direction on clinical database design to clients and internal teams.

• Create, support, develop, test, and validate clinical databases, programs, and third-party applications.

• Deliver system administration and advanced technical support.

• Diagnose and rectify software and clinical database issues.

• Produce and maintain validation documents specific to studies.

• Assist data management from CRF design through database closure and archival.

• Engage in software vendor selection, EDC demonstrations, training sessions, SOP development, and process documentation.

• Aid in the onboarding of new employees.

• Provide leadership for cross-functional and organization-wide initiatives.

• Liaise with study sponsors, vendors, and project teams concerning project challenges.

• Conduct software demonstrations, training sessions, and project meetings.

• Perform duties in compliance with SOPs, government regulations, guidelines, and industry standards.

• May necessitate some travel.

• Execute other responsibilities as assigned.

⛳️ Requirements

• A minimum of 8 years of experience.

• Bachelor's degree and/or a combination of related experience.

• Strong background in Oncology.

• Experience with Autoimmune diseases is a significant advantage.

• Extensive experience with Rave and Veeva.

• Proficient in Microsoft Office: Word, Excel, PowerPoint, Outlook.

• Experience in Object Oriented Programming (C#, C++, VBS, etc.).

• Familiarity with CDISC standards (CDASH, SDTM, ADaM, etc.).

• Proficient in multiple CDMS systems, including form building, edit checks, and complex rule development.

• Awareness of CRF standards and contribution to the maintenance of standards library.

• Ability to troubleshoot and assist peers with technical issues while developing solutions.

• Comprehensive knowledge of drug, device, and/or biologic development along with effective data management practices.

• Capable of managing various clinical research tasks.

• Exceptional organizational and communication skills.

• Professional proficiency in the English language, both written and spoken.

• Experience in the development of clinical database management systems.

• Background in a clinical, scientific, or healthcare field.

• Strong leadership and interpersonal abilities.

🏝️ Benefits

• Full-time, permanent position.

• Fully remote work from locations within Europe.

• Equal Opportunity Employer.

• Reasonable accommodations available for the application process.