Principal Database Programmer

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

📋 Description

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

• Take responsibility for assigned projects, ensuring timely delivery.

• Relay project status, contract parameters, and work updates to both internal teams and study teams.

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

• Provide insights and recommendations on the design of clinical databases.

• Construct, develop, test, and support clinical databases.

• Create, test, and validate programs and clinical databases for client projects and external applications.

• Offer system administration and advanced technical assistance.

• Diagnose and resolve software and clinical database issues.

• Develop and sustain study-specific validation documentation.

• 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 creation and maintenance of SOP and process documentation.

• Facilitate the onboarding process for new employees.

• Lead cross-functional initiatives and organization-wide projects.

• Train members of the data management project team as well as end-users.

• Interact with sponsors, vendors, and project teams regarding project-related challenges.

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

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

• Perform additional duties as assigned.

⛳️ Requirements

• At least 8 years of relevant experience.

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

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

• Significant experience with Rave and Veeva.

• Skilled in Microsoft Office Suite: Word, Excel, PowerPoint, 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.

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

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

• Capable of handling a diverse range of clinical research activities.

• Exceptional organizational and communication abilities.

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

• Experience in clinical database management system development.

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

• Strong leadership and interpersonal capabilities.

🏝️ Benefits

• Full-time, permanent position.

• Fully remote work available from European locations.

• Potential for some travel requirements.