Clinical Database Programmer

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

📋 Description

• Oversee and implement comprehensive clinical database programming tasks for designated clinical trials.

• Design, construct, configure, test, and sustain electronic data capture databases.

• Create and execute edit checks, derivations, form logic, field dynamics, and other functionalities within the database.

• Generate, validate, and uphold data transfer specifications along with external data integrations.

• Load, reconcile, and manage non-CRF data sourced from external entities.

• Determine data collection needs with study teams and ensure alignment with protocol goals and regulatory requirements.

• Uphold data standards, principles of data integrity, and quality expectations throughout the lifecycle of clinical data.

• Review and offer insights on data management strategies, study documentation, CRFs, edit check specifications, and associated materials.

• Facilitate study milestones by ensuring the timely delivery of complete, precise, and dependable clinical data.

• Participate in database lock procedures and maintain readiness for inspections and audits.

• Develop, test, and manage reports, listings, dashboards, and data review tools utilizing SQL, SAS, or other reporting technologies.

• Employ data analytics and reporting tools for data review, issue identification, and study monitoring.

• Resolve database and data management programming challenges in collaboration with IT and system vendors.

• Act as a technical expert in clinical database programming and EDC functionality.

• Cultivate working relationships with cross-functional stakeholders involved in the execution of clinical studies.

• Relay updates on study progress, risks, and technical aspects to project teams and management.

• Offer guidance and mentorship to team members when appropriate.

• Engage in initiatives aimed at process improvement and advance standards, tools, and best practices in data management.

• Identify opportunities to enhance efficiency, quality, and consistency in clinical data management programming processes.

• Assist in the adoption of new technologies, methodologies, and industry best practices.

• Contribute to departmental initiatives and organizational objectives related to clinical systems and data management.

⛳️ Requirements

• Bachelor’s degree in Computer Science, Life Sciences, Information Systems, Mathematics, Statistics, or a related discipline; or a comparable combination of education and relevant experience.

• A minimum of 3 years of experience in clinical database programming or clinical data management within the pharmaceutical, biotechnology, medical device, or contract research organization (CRO) sectors.

• Experience with clinical studies from the database build phase to database lock and archival.

• Familiarity with Veeva CDMS, Veeva EDC, or similar electronic data capture platforms.

• Strong grasp of clinical trial processes, data management principles, and activities in the clinical data lifecycle.

• Knowledge of FDA, ISO, ICH-GCP, and relevant regulatory standards governing clinical research and data management.

• Understanding of relational database design and data structures.

• Proficient in SQL programming and techniques for data extraction.

• Experience with EDC systems, preferably Veeva CDMS.

• Familiarity with MedDRA and WHO Drug coding dictionaries.

• Strong analytical, problem-solving, and troubleshooting abilities.

• Capacity to manage multiple priorities and adhere to project timelines in a dynamic environment.

• Excellent written and verbal communication skills.

• Effective collaboration and stakeholder management abilities within cross-functional teams.

• Proficiency with Microsoft Office applications and clinical research technologies.

• Ability to stay in a stationary position for extended periods.

• Frequent use of a computer, keyboard, and other office equipment.

• Effective communication through both written and verbal means.

• Occasional travel of up to 10% may be necessary based on business requirements.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Opportunities for rewards and recognition.

• Competitive compensation and benefits packages.

• Opportunities for learning, growth, and development.

• Flexible work-life balance.

• Remote or field-based workplace arrangements as applicable.

• Commitment to equal opportunity employment.

• Reasonable accommodations for individuals with disabilities.

• Potential employment support or accommodations related to COVID-19 vaccination, where applicable.