We at #CosMicIT GmbH are urgently looking for a #EDC Veeva Database Programmers
Location: #Switzerland, Germany, Poland, The Netherlands, Hungary
As the Electronic Data Capture Engineer, you will work on Veeva Electronic Data Capture (EDC) activities and will oversee delivery of systems and documentation to support Clinical studies. You will work with Client study team to develop eCRF specifications, build or oversee implementation of Case Report Forms (eCRFs) for clinical trials. Manage and oversee EDC system configuration and dictionaries. You will provide consulting services to ensure implementation of technology.
You will work with Data Management and standards teams to implement new study builds and oversee existing one following Client processes. You will enhance existing processes for efficient and compliant way of Clinical trial build. The Electronic Data Capture Engineer maintains and serves as an expert for implementation of EDC best practices.
The Electronic Data Capture Engineer would be familiar with leading EDC technologies available on the market. You will continue developing new skills associated with EDC technologies.
- Create eCRF specifications, design, develop and validate clinical trial setup process
- Create edit check specifications and setup edit checks at trial level
- Implement UAT scripts to test the setup of the clinical study
- Setup different instances of study URL(eg: UAT, production, testing etc.,)
- Setup and configure user accounts for study teams
- Setup and manage blinded and unblinded study configurations
- Be the SME for all EDC database related activities
- Setup, configure, validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,
- Understanding of when custom functions are required within EDC systems
- Ability to troubleshoot database setup as per study needs
- Prepare, test and implement post production changes as per study needs
- Partner with team members to establish technology standards & governance models
- Oversee system delivery life cycle in collaboration with appropriate partners including
Clinical Operations, Clinical Supplies, IT, and Quality organizations
- Be a primary change agent to ensure adoption of new capabilities and business process
- Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.
- Work with leaders to resolve issues affecting the delivery of clinical trials
- Work closely with data engineers and data management programmers on study level integrations and deliveries
- Lead technology vendor oversight activities.
- Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.
- Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents
- Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.
- Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.
- Adaptable to new ways of working using technology to accelerate clinical trial setup
Education and Experience Requirements:
- Bachelor’s degree or related experience.
- Knowledge of drug development process.
- 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical
Research related fields.
- Hands-on experience with Veeva(mandatory), Medidata Rave/ Oracle Inform
- Experience programming in CQL, CDB, working with JSON format and/or C# is
preferred but not required
- Experience integrating other clinical trial modules (eg: lab, safety, IRT, coding, etc.,) with the EDC system
- Understanding of industry standard technologies to support Clinical Development needs (e.g. CTMS, SAS, R or Python, Data Warehouses, Sharepoint)
NOTE: For the above positions, we only consider candidates with work visa holders or citizens of European countries
If any of these openings sound familiar to you or any of your known networks, please share the resume/CV to CV@cosmic-it.com
Any references would also be accepted.
CosMicIT Informatics India Pvt Ltd.
CosMicIT Spolka Z Ograniczona Odpowiedzialnoscia, Poland
www.CosMic-IT.com | www.CosMic-IT.in
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