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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical database programming and data management, with proficiency in SQL and EDC systems such as Veeva CDMS. Capable of leading end-to-end clinical data activities while ensuring compliance with regulatory standards and data integrity principles.
Highest-signal resume keywords
Clinical Database ProgrammingSQL ProgrammingVeeva CDMSData Management PrinciplesRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
SQL ProgrammingDatabase DesignData Extraction TechniquesElectronic Data CaptureData Transfer SpecificationsEdit Checks DevelopmentData ReconciliationData Integrity PrinciplesStatistical AnalysisClinical Trial Processes
Soft Skills
Analytical SkillsProblem-Solving SkillsCommunication SkillsCollaboration SkillsStakeholder Management
Tools & Technologies
Veeva EDCMicrosoft OfficeClinical Research TechnologiesData Review ToolsReporting Technologies
Industry Keywords
Clinical Data ManagementPharmaceutical IndustryBiotechnologyMedical DeviceContract Research OrganizationFDA RegulationsISO StandardsICH-GCPMedDRAWHO Drug Coding
Tech Stack
Tools & technologiesSQL
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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