- Mahwah, NJ, 07430, US
- Remote-US
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Job description
Stryker is hiring a Clinical Programmer, EHR and Integration. This position is Remote, supporting our Trauma & Extremities Division.
What you will do
This position will partner with key stakeholders, as well as in a team to develop databases in the Medidata platform, clinical data is captured and processed for analysis and reporting. This position specializes in the creation of workflows to allow the ingestion of EMR data into Medidata EDC; this is achieved using the Health Record Connect module in the Medidata platform, along with traditional batch import methodologies.
- Develop, test, and release workflows for automated ingestion of secondary data sources such as EMR through Health Record Connect and traditional Push-Pull sources. Establish with site staff the potential for linkages or batch upload of data.
- Work with the Data Managers, Study team, Vendors, and Site Staff, to create Data Transfer plans for secondary data sources (e.g. Lab data, Site data). Batch Import agreed data sources into the EDC.
- Create ad-hoc reports via Business Objects or JReview.
- Experience with Medidata Custom Functions (C#) would be an advantage.
- Develop, program, validate and maintain Medidata Rave EDC clinical trial databases according to company standards. Create EDC design specifications that include the data dictionary, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form and event rules.
- Work with the Data Managers and study teams to design and build EDC database based on global eCRF libraries.
- Configure and optimize multiple patient user interfaces to support different modes of data collection (eCOA- mobile device or tablet, EDC- laptop/desktop computer)
- Perform, test, and Produce Rave EDC Migration activities as required
- Develop test scripts and coordinate EDC user acceptance testing (UAT) to ensure accuracy of database structure, content, and validation controls based on the original specifications
- Coordinate and manage the release of new or amended EDC databases into production.
- Assist with mapping the EDC database to the company enterprise data warehouse.
- As part of continuous improvement, develop and implement EDC design standards to improve quality and streamline database build efforts. Provide input into development and revisions of department SOPs.
What you will need
- Bachelor’s degree in a technical and/or scientific discipline required.
- Minimum 6+ years of experience managing clinical studies in a data management role (Device, Pharma, or Biotech).
- Strong proficiency in EDC systems (Medidata Rave), in particular Health Record Connect required.
- Familiarity with structure of EMR systems (e.g. EPIC, Cerner) required.
- Experience with Medidata Batch Uploader required.
Preferred
- M.S in health/science-related field
- Experience configuring other modules (TSDV, eCOA, eConsent, RSR, eTMF, CTMS, etc) within the Medidata Suite.
- Experience creating custom/ad hoc reports with JReview and/or Business Objects.
- Experience in Clinical Research within the medical device industry.
- $117,600.00 - 193,900.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.