Principal Database Programmer

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

📋 Description

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

• Take ownership of assigned projects, ensuring timely delivery.

• Update internal teams and study teams on project status, contract scope, and work progress.

• Predict project hours, determine resource needs, and manage project budgets effectively.

• Offer insights and advice on the design of clinical databases.

• Construct, support, develop, test, and validate clinical databases, programs, and applications.

• Provide system administration and advanced technical assistance.

• Diagnose and resolve software and clinical database issues.

• Create and maintain study-specific validation documents.

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

• Engage in software vendor selection, EDC demonstrations, and training sessions.

• Contribute to the development and upkeep of SOPs and process documentation.

• Lead operational study teams and programming team members.

• Deliver operational and technical training to end users, junior staff, and data management project team members.

• Aid in the onboarding process for new hires.

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

• Coordinate with sponsors, vendors, and project teams concerning project-related issues.

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

• Execute responsibilities in alignment with SOPs, regulations, guidelines, and industry standards.

• Carry out other assigned tasks.

⛳️ Requirements

• At least 8 years of relevant experience.

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

• Extensive experience in Oncology; familiarity with Autoimmune diseases is a significant plus.

• Strong expertise in Rave and Veeva platforms.

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

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

• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).

• Proficient in multiple CDMS systems, including the creation of forms, edit checks, and complex rule development.

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

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

• Comprehensive knowledge of drug, device, and/or biologic development and best practices in data management.

• Capable of managing a range of clinical research tasks.

• 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 opportunity from locations within Europe.

• Potential for some travel as needed.