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
Skills Required
- 3 years of clinical data management experience
- Ability to program using SQL
- Experience with EDC systems (e.g., Veeva CDMS, Medidata RAVE)
- Experience with Veeva EDC and Veeva CDB
- Bachelor's degree in a related field
- Proficient computer skills with understanding of clinical systems and data administration
- Experience maintaining global clinical trial database standards (CDISC)
- Must be organized and an effective written and oral communicator
- Ability to multi-task in a fast-paced environment and build strong relationships
What We Do
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
