Job Title: Clinical Database Builder EHR & Integration (Remote)
Job Location: Mahwah NJ 07430 USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
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Stryker is hiring a Clinical ProgrammerEHR 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 PushPull 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 adhoc 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/sciencerelated 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.
$117600..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.
Health benefits include: Medical and prescription drug insurance dental insurance vision insurance critical illness insurance accident insurance hospital indemnity insurance personalized healthcare support wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA) Flexible Spending Accounts (FSAs) 401(k) plan Employee Stock Purchase Plan (ESPP) basic life and AD&D insurance and shortterm disability insurance. Stryker offers innovative products and services in MedSurg Neurotechnology Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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