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Clinical Programmer Ii (Veeva/Inform/Rave)

3-6 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The Clinical Programmer II role at Syneos Health involves developing and managing programming solutions to support clinical trials. Below is a summary of the key responsibilities and qualifications for this position:


Key Responsibilities:

  • Database Development:

    • Use Oracle RDC, Oracle Inform, Medidata Rave, SAS, and similar tools to design, validate, and maintain databases.
    • Develop specifications, code annotated CRFs, create databases, configure edit checks, and manage import/export setups.
    • Generate listings and custom reports as required for clinical studies.
  • Project Coordination:

    • Serve as the lead programmer on multiple studies, managing programming activities, and coordinating with project teams.
    • Ensure timely delivery by communicating project status, resource needs, and potential risks.
    • Participate in Quick Start Camps (QSCs) and project reviews, contributing to efficient project kick-offs.
  • Quality Assurance:

    • Review core deliverables for accuracy and attend sponsor audits.
    • Monitor study budgets and address scope changes proactively.
    • Ensure deliverables comply with specifications and standards.
  • Leadership and Collaboration:

    • Train and support peers and team members on technical and programming tasks.
    • Collaborate with sponsors, internal stakeholders, and external partners to finalize specifications.
    • Provide input during departmental and project review meetings.
  • Continuous Improvement:

    • Stay updated on industry trends, tools, and best practices through training, literature, and professional events.
    • Suggest improvements to existing processes to enhance efficiency and quality.

Required Qualifications:

  • Education: Bachelor's degree preferred, or equivalent education/experience.
  • Experience:
    • 2–6 years of experience in database programming, preferably with InForm, Rave, or Veeva.
    • Proven experience in designing eCRFs and programming edit checks using EDC systems (e.g., Central Designer for Inform).
  • Technical Skills:
    • Familiarity with programming languages like PL/SQL, SAS, C#, or VB.
    • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
  • Soft Skills:
    • Excellent written and verbal communication skills.
    • Strong interpersonal skills for managing relationships with sponsors and internal teams.
    • Ability to prioritize tasks and work in a dynamic, matrix-structured environment.
  • Travel: Ability to travel up to 25%.

Preferred Qualifications:

  • Experience with database programming for clinical trials in a matrix-structured organization.
  • Demonstrated ability to handle multiple projects simultaneously.
  • Familiarity with both technical and clinical aspects of programming for trials.

This role offers the opportunity to work in a fast-paced environment with Syneos Health, contributing to advancements in global biopharmaceutical solutions.