Posted 8 months ago

EDC Developer / Programmer

Remote - USRemoteFull-time

AI Summary

The EDC Developer / Programmer designs, builds, and administers electronic data capture (EDC) databases and eCRFs for clinical research projects, serving as a subject-matter expert on Veeva CDMS and related tools.

About this role

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!

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

#LI-Remote

Skills

CDISCClinical Reporting ToolsData Transfer StandardsECRF DesignEDC SystemsEdit Check ProgrammingSQLVeeva Clinical Database (CDB)Veeva Clinical Data Management Suite (CDMS)Veeva Electronic Data Capture (EDC)

EDC Developer / Programmer

About this role

In this role you will:

Requirements:

Skills

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