Note: The job is a remote job and is open to candidates in USA. BD is a global medical technology company focused on advancing health through innovative healthcare products and solutions. The Clinical Database Programmer designs, develops, implements, maintains, and supports clinical databases and data management programming activities for clinical studies. This role ensures high-quality, analysis-ready data while collaborating with cross-functional teams from study start-up through database lock and archival.
Responsibilities
- Lead and execute end-to-end clinical database programming activities for assigned clinical studies
- Design, build, configure, test, and maintain electronic data capture (EDC) databases according to study requirements and approved specifications
- Develop and implement edit checks, derivations, form logic, field dynamics, and other database functionality to support data quality and study objectives
- Create, validate, and maintain data transfer specifications and external data integrations
- Perform loading, reconciliation, and processing of non-CRF data from external sources
- Partner with study teams to define data collection requirements and ensure alignment 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 study documentation
- Support study milestones by ensuring timely delivery of complete, accurate, and reliable clinical data
- Contribute to database lock activities and support inspection and audit readiness as required
- Develop, test, and maintain reports, listings, dashboards, and data review tools using SQL, SAS, or other reporting technologies
- Utilize data analytics and reporting solutions to facilitate data review, issue identification, and study oversight
- Troubleshoot database and data management programming issues and collaborate with IT and system vendors to implement solutions
- Serve as a technical subject matter expert for clinical database programming and EDC functionality
- Establish and maintain effective 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 other team members as appropriate
- Participate in process improvement initiatives and contribute to the advancement of 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
Skills
- 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
- Hybrid or remote work environment.
Company Overview
Company H1B Sponsorship