Principal Database Programmer

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

📋 Description

• Oversee all programming components of clinical databases and applications from the initiation of the study until after the database is locked.

• Direct assigned projects and ensure timely completion.

• Relay project status updates to internal teams and study stakeholders.

• Supervise contract scope and project requirements.

• Anticipate hours, determine resource needs, and manage project financials.

• Offer insights and guidance on clinical database architecture.

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

• Deliver system administration and advanced technical assistance.

• Diagnose and resolve software and clinical database issues.

• Create and maintain study-specific validation documentation.

• Assist in data management from CRF design 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.

• Aid in the onboarding process for new hires.

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

• Train members of the data management project team and end users.

• Liaise with sponsors, vendors, and project teams regarding project-related concerns.

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

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

• May involve some travel.

• Perform additional duties as assigned.

⛳️ Requirements

• At least 8 years of experience.

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

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

• Strong expertise with Rave and Veeva.

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

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

• Knowledge of 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 contributions to the maintenance of the standards library.

• Capability to troubleshoot and assist peers with technical challenges and devise solutions.

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

• Able to manage a diverse range of clinical research responsibilities.

• Exceptional organizational and communication skills.

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

• Experience in developing 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 European locations.

• Equal Opportunity Employer.

• Reasonable accommodations available during the application process.