Principal Database Programmer

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

📋 Description

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

• Ensure timely delivery and provide updates on project status to internal and study teams.

• Supervise contract elements and the scope of work for designated projects.

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

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

• Construct and maintain clinical databases.

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

• Deliver system administration and advanced technical assistance.

• Diagnose and resolve software and clinical database issues.

• Create 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, training sessions, and SOP development.

• Facilitate the onboarding process for new employees and spearhead cross-functional initiatives.

• Train members of the data management project team.

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

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

• Carry out responsibilities in alignment with SOPs, government regulations, guidelines, and industry standards.

• Travel may be required along with other assigned duties.

⛳️ Requirements

• At least 8 years of relevant experience.

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

• Extensive experience in Oncology; familiarity with Autoimmune diseases is highly advantageous.

• Significant experience with Rave and Veeva.

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

• Experience with 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.

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

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

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

• Ability to manage a range of clinical research tasks.

• Exceptional organizational and communication skills.

• Professional command of the English language, both verbally and in writing.

• Experience in the development of clinical database management systems.

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

• Strong leadership and interpersonal capabilities.

🏝️ Benefits

• Full-time, permanent position.

• Fully remote work opportunity from European locations.

• Commitment to equal opportunity employment.

• Reasonable accommodations provided for applicants with disabilities.