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Principal Clinical Database Programmer
ParexelPrincipal Clinical Database Programmer at Parexel recognized as a subject matter expert in clinical data management. Leading teams and providing technical guidance on clinical data systems while ensuring compliance and quality.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Clinical Data Programming, with a strong focus on Electronic Data Capture Systems and adherence to regulatory compliance. Proven ability to lead programming teams, mentor staff, and ensure successful project execution within timelines and budgets.
Highest-signal resume keywords
Clinical Data ProgrammingElectronic Data Capture SystemsSASProject LeadershipRegulatory 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
SASSQLVBJavaCDMSEDCSoftware Development Life CycleClinical Trial ProcessECRF CreationData Management
Soft Skills
Team LeadershipMentoringCommunicationCollaborationProblem Solving
Tools & Technologies
InformRAVEDataLabsMedrioVeevaCTMS
Certifications & Qualifications
Build Certified
Industry Keywords
Clinical ResearchSOPsICH-GCP21 CFR Part 11Regulatory Guidelines
Tech Stack
Tools & technologiesGoogle Cloud PlatformJavaSDLCSQL
About the role
Key responsibilities & impact- The Principal Clinical Database Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors
- 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)
- Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems
- Provide feedback for study programmers on the creation of eCRF’s following SOPs and internal process guidelines
- Coordinate and lead a programming team to successful completion of a study within given timelines and budget
- Interact with Sponsors and Data Management Leaders as the key contact regarding programming related issues
- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance
- Act as a mentor and/or SME providing, creating and implementing relevant training for staff.
Requirements
What you’ll need- 8+ 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
- Strong 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
- Team and Project leadership experience required.
Benefits
Comp & perks- Professional development opportunities