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Senior RAVE Clinical Database Programmer

Katalyst CRO

Role overview

Qualifications

  • Advanced knowledge of CRF design
  • Experience with database configuration and programming
  • Proficiency in system integrations and CDMS functionality
  • Ability to collaborate with cross-functional teams

Responsibilities

  • Serve as the primary owner of study-specific database design within the CDMS
  • Review database specification documents and build clinical study database CRF screens
  • Plan and coordinate edit check test script development and validation activities
  • Lead and support database migration activities and database maintenance

Key facts

Hard skills

Other skills

  • Problem Reporting
  • Troubleshooting (Problem Solving)
  • Problem Solving
  • Communication
  • Teamwork
  • Time Management

About the company

Katalyst CRO logo

Katalyst CRO

Contract Research Organizations (CRO)

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Company details

IndustryContract Research Organizations (CRO)
Company size51 - 200

Links

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Job description

Job Description:
The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution.
Key Responsibilities:
  • Serve as the primary owner of study-specific database design within the CDMS (e.g., Medidata Rave; experience preferred), leading clinical database programming activities across multiple studies of complex design.
  • Review database specification documents created by study teams, including CRF Specifications and Data Validation Specifications (DVS).
  • Build clinical study database CRF screens based on approved CRF Specifications.
  • Program edit checks, special actions/functions, custom programs, and derivations in accordance with the DVS.
  • Plan and coordinate edit check test script development, programming, validation, and User Acceptance Testing (UAT) activities. Ensure issues are resolved in a timely manner and produce validation documentation for study teams and the Trial Master File (TMF).
  • Complete study database updates in accordance with Change Request documentation and procedures, including performing impact analyses and risk assessments for proposed changes.
  • Lead and support database migration activities, including live study updates and database maintenance.
  • Partner with Clinical Data Management, Clinical Operations, Biostatistics, and external vendors to coordinate clinical database programming activities and ensure alignment with study timelines and objectives.
  • Participate in project meetings, contribute to problem-solving discussions, communicate project risks, and proactively escalate issues that may impact timelines, scope, or quality.
  • Balance multiple study assignments while effectively managing priorities and communicating resource needs.
  • Troubleshoot and resolve study build, system integration (e.g., IVRS, CTMS), and change request issues using the appropriate applications.
  • Develop advanced custom programs and functionality as required by study specifications.
  • Ensure high-quality deliverables by reviewing study-level, program-level, and multi-study core deliverables for accuracy, completeness, and compliance.
  • Participate in departmental initiatives, user group meetings, and knowledge-sharing activities to promote best practices and awareness of new system features.
  • Develop detailed study execution plans, including programming, testing, and UAT milestones, providing clear visibility into study startup progress and key deliverables.
  • Support the ongoing evolution of internal EDC capabilities by serving as a technical resource to cross-functional study teams and helping establish efficient database programming processes.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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