Celerion

EDC Developer / Programmer

Celerion  •  United States (Remote)  •  17 days ago
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Job Description

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 
Celerion Values:       Integrity   Trust   Teamwork   Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
Celerion

About Celerion

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings.

Our operations are strategically located in:

Lincoln, Nebraska (Corporate Headquarters)

Philadelphia, Pennsylvania

Phoenix, Arizona

Belfast, Northern Ireland,UK

Zurich, Switzerland

Vienna, Austria

Richmond, Virginia

Montreal, Quebec, Canada

For more information, visit: www.celerion.com

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Lincoln, NE
Year Founded
2010
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