Clinical Database Programmer
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Job Description
Clinical Database Programmer building and validating clinical trial databases for Waters’ analytical life sciences and informatics business. Supporting data quality, database lock, reporting, and regulatory compliance.
Responsibilities:
- Lead and execute end-to-end clinical database programming activities for assigned clinical studies
- Design, build, configure, test, and maintain electronic data capture databases
- Develop and implement edit checks, derivations, form logic, field dynamics, and other database functionality
- Create, validate, and maintain data transfer specifications and external data integrations
- Load, reconcile, and process non-CRF data from external sources
- Define data collection requirements with study teams and align them with protocol objectives and regulatory expectations
- Enforce data standards, data integrity principles, and quality expectations throughout the clinical data lifecycle
- Review and provide input on data management plans, study documents, CRFs, edit check specifications, and related documentation
- Support study milestones through timely delivery of complete, accurate, and reliable clinical data
- Contribute to database lock activities and inspection and audit readiness
- Develop, test, and maintain reports, listings, dashboards, and data review tools using SQL, SAS, or other reporting technologies
- Use data analytics and reporting solutions for data review, issue identification, and study oversight
- Troubleshoot database and data management programming issues with IT and system vendors
- Serve as a technical subject matter expert for clinical database programming and EDC functionality
- Establish working relationships with cross-functional stakeholders involved in clinical study execution
- Communicate study progress, risks, and technical considerations to project teams and management
- Provide guidance and mentorship to team members as appropriate
- Participate in process improvement initiatives and advance data management standards, tools, and best practices
- Identify opportunities to improve efficiency, quality, and consistency across clinical data management programming processes
- Support implementation of new technologies, methodologies, and industry best practices
- Contribute to departmental initiatives and organizational goals related to clinical systems and data management
Requirements:
- Bachelor's degree in Computer Science, Life Sciences, Information Systems, Mathematics, Statistics, or a related field; or an equivalent combination of education and relevant experience
- Minimum of 3 years of clinical database programming or clinical data management experience within the pharmaceutical, biotechnology, medical device, or contract research organization (CRO) industry
- Experience supporting clinical studies from database build through database lock and archival
- Experience with Veeva CDMS, Veeva EDC, or equivalent electronic data capture platforms
- Strong understanding of clinical trial processes, data management principles, and clinical data lifecycle activities
- Knowledge of FDA, ISO, ICH-GCP, and applicable regulatory requirements governing clinical research and data management
- Understanding of relational database design and data structures
- Proficiency in SQL programming and data extraction techniques
- Experience with EDC systems, preferably Veeva CDMS
- Familiarity with MedDRA and WHO Drug coding dictionaries
- Strong analytical, problem-solving, and troubleshooting skills
- Ability to manage multiple priorities and meet project timelines in a fast-paced environment
- Excellent written and verbal communication skills
- Effective collaboration and stakeholder management skills within cross-functional teams
- Proficiency with Microsoft Office applications and clinical research technologies
- Ability to remain in a stationary position for extended periods of time
- Frequent use of a computer, keyboard, and other office equipment
- Ability to communicate effectively through written and verbal means
- Occasional travel up to 10% may be required based on business needs
Benefits:
- Comprehensive Total Rewards program
- Reward and recognition opportunities
- Competitive compensation and benefits programs
- Learning, growth, and development opportunities
- Flexible work-life balance
- Remote or field-based workplace arrangements where indicated
- Equal opportunity employment
- Reasonable accommodations for individuals with disabilities
- Potential COVID-19 vaccination-related employment support or accommodations, where applicable
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