Principal Database Programmer

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

📋 Description

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

• Spearhead the testing, implementation, maintenance, and support of clinical databases and applications.

• Take ownership of assigned projects and ensure timely delivery.

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

• Project future hours, determine resource needs, and manage project budgets, including out-of-scope work and changes after production.

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

• Construct and provide support for clinical databases.

• Create, test, and validate programs and clinical databases for client projects and third-party applications.

• Deliver system administration and advanced technical support.

• Diagnose and resolve software and clinical database issues.

• Create and maintain validation documents specific to studies.

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

• Design, develop, and validate internal, client-related, and third-party applications as necessary.

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

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

• Aid in the onboarding process for new hires.

• Lead initiatives that span multiple functions and organizational areas where applicable.

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

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

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

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

• Perform additional duties as assigned.

⛳️ Requirements

• At least 8 years of experience in the field.

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

• Significant experience in Oncology; familiarity with Autoimmune diseases is a distinct advantage.

• Extensive experience with Rave and Veeva.

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

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

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

• Proficient in multiple CDMS systems, including form creation, 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 issues and create effective solutions.

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

• Capable of managing various clinical research tasks.

• Exceptional organizational and communication abilities.

• Professional command of the English language in both written and spoken forms.

• Experience in developing clinical database management systems.

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

• Strong leadership and interpersonal skills.

• Preferred/optional: experience across multiple therapeutic areas; familiarity with various Database Programming systems; ability to work autonomously and manage time efficiently; capability to function effectively with minimal guidance; collaboration and knowledge sharing skills; organization, prioritization, customer service orientation, client relationship management, and negotiation skills.

🏝️ Benefits

• Full-time, permanent position.

• Fully remote work opportunity from locations within Europe.

• Some travel may be required.