EDC Developer / Programmer

Celerion

$80K — $120K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a related field preferred
  • 3 years of clinical data management experience
  • Ability to program using SQL required
  • Experience with EDC systems (i.e. Veeva CDMS, Medidata RAVE, etc.)
  • Experience with Veeva EDC and Veeva CDB preferred
  • Proficient computer skills with understanding of clinical systems and data administration
  • Excellent organizational and communication skills

Responsibilities

  • Serve as subject matter expert in Veeva Clinical Data Management Suite
  • Perform eCRF design and EDC build programming
  • Program EDC edit checks based on specifications
  • Create test data for screen design and edit checks
  • Set up test environments and coordinate testing execution
  • Program and configure listings and reports using clinical reporting tools
  • Ensure secure database imports from vendor transfers
  • Assist with validation of hardware/software upgrades

Benefits

  • Full-time remote opportunity
  • Potential travel for training and key meetings
  • Dynamic and fast-paced work environment
  • Opportunity to support creating life-saving treatments
  • Exposure to innovative research strategies and methods
Full Job Description
We are looking for a performance-oriented, innovative and self-motivated team player to join our Clinical Data Sciences team as a full-time Electronic Data Capture (EDC) Database Developer / Clinical Programmer. You will be responsible for administration of EDC Database including evaluation, analysis, design and/ or recommendations to achieve goals and excellent results in a fast-paced, ever-changing environment.

This is a full time, remote opportunity, but may travel for training and key meetings.

As an EDC Database Developer, you will build and administer EDC trials for client contracted projects including protocol/requirements evaluation, electronic case report form (eCRF) design and build with corresponding edits. This role will have technical interaction with vendors that are supporting the applications and troubleshoot/ escalate problems on systems to appropriate partners. This role will provide expert guidance to the design, development, validation, implementation and maintenance of study set-up. Additionally, this role will manage the deployment of EDC trials and set up interface connections between EDC and other systems.

In this role you will:

  • Serve as a subject matter expert in Veeva Clinical Data Management Suite (CDMS), including Veeva Electronic Data Capture (EDC) and Veeva Clinical Database (CDB)
  • Perform all activities related to eCRF design and EDC build programming for assigned projects
  • Perform EDC edit check programming for assigned projects based on edit check specifications for both simple and complex edit checks
  • Create test data to verify both screen design and edit check programming prior to deploying to User Acceptance Testing (UAT)
  • Set up test environments and coordinate project team members for execution of test scripts
  • Program and configure listings and reports using clinical reporting tools such as Veeva Clinical Database (CDB)
  • Ensure secure and high-integrity database imports from vendor transfers using Celerion data transfer standards
  • Assist with the validation of upgrades to hardware/ software including validation documentation development, review and execution.
  • Maintain global clinical trial database standards (CDISC)


Requirements:

  • Bachelor's degree in a related field preferred
  • 3 years of clinical data management experience
  • Ability to program using SQL required
  • Experience with EDC systems (i.e. Veeva CDMS, Medidata RAVE, etc.)
  • Experience with Veeva EDC and Veeva CDB preferred
  • Proficient computer skills with understanding of clinical systems and data administration
  • Must be organized, an effective written and oral communicator
  • Must have the ability to multi-task, within a fast-paced environment, and build strong relationships


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