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Senior Clinical Database Programmer
ParexelSenior Clinical Database Programmer at Parexel improving clinical trial processes through technical expertise and programming activities. Leading database setups and ensuring first time quality in deliverables.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Programming and the management of clinical trials, with a strong focus on adherence to regulatory guidelines such as ICH-GCP and 21 CFR Part 11. Proficient in utilizing various clinical systems and programming environments to ensure high-quality deliverables and effective project management.
Highest-signal resume keywords
Clinical Data ProgrammingSASEDCGCP21 CFR Part 11
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Data ProgrammingSASEDCSQLVBJavaDatabase ManagementSoftware Development Life CycleClinical Trial ProcessTechnical Support
Soft Skills
CommunicationLeadershipProject ManagementProblem SolvingCollaboration
Tools & Technologies
CDMSCTMSMedical Safety ReportingInformRAVEDataLabsMedrioVeeva
Certifications & Qualifications
Build Certified
Industry Keywords
Clinical TrialsICH GuidelinesRegulatory ComplianceSOPsWork Instructions
Tech Stack
Tools & technologiesGoogle Cloud PlatformJavaSDLCSQL
About the role
Key responsibilities & impact- Provide technical expertise for the conduct of clinical trials
- Act as an internal subject matter expert in specific areas providing technical support and expert advice
- Work independently to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies
- Assist with the Database Primary or Technical Lead role on projects
- Liaise with sponsors, Data Management Lead and other functional areas as required
- Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper-based and/or web-based (EDC) clinical data management systems (CDMS)
- Ensure that timelines are adhered to
- Monitor project resourcing and identify changes in scope
- Ensure first time quality on all deliverables
Requirements
What you’ll need- 6 to 7 Years of experience in Clinical Data Programming
- Experience in at least one programming environment (e.g. SAS, CDMS, EDC, SQL, VB, Java)
- Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
- Experience working with at least two systems used within the Clinical Trial process (e.g. SAS, CDMS, EDC (Inform, RAVE, DataLabs, Medrio, Veeva), CTMS, Medical Safety Reporting) is desirable
- Build Certified in at least one system, if available
- Strong experience in clinical research industry or similar field is required
- Knowledge of Software Development Life Cycle (SDLC) methodologies
- Knowledge of GCP, 21 CFR Part 11 and other relevant ICH/regulatory guidelines
- Written and oral fluency in English.
Benefits
Comp & perks- Health insurance
- Professional development opportunities