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CRO – Electronic Data Capture (EDC) Developer, Contract Role
Evolution Research Group
contract
Posted on:
Location Type: Remote
Location: Remote • New Jersey • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Develop, program, validate and maintain EDC clinical trial databases in accordance with study protocols and/or source documentation.
- Lead post-production discussions and assist with closing functional gaps and required remediation.
- Generate and maintain all required documentation related to programming activities; ensure quality of the programming and adherence to company standards.
- Identify and recommend how to optimize CRO processes based on tool functionality.
- Assist with management of external application vendor responsibilities, integrations, and implementations.
- Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs.
- Actively participate in database-related user groups, to include standard forms workgroups and process improvement workgroups.
- Assists the Biostats and Data Management teams in the development and delivery of a variety of complex data processing, reports, and dashboards.
- Provides technical guidance and leadership to less-experienced individuals regarding IT functions, EDC programming, etc.
- Communicates with cross functional groups throughout the project lifecycle.
- Monitors project scope.
- Maintain a strong understanding of departmental and company procedures.
- Maintains key vendor relationships such as EDC system vendors, etc.
- Contribute to maintenance of EDC template database.
- Identify processes that will increase productivity, quality and efficiency.
- Performs other miscellaneous related duties, as required.
Requirements
- BS/BA preferred
- School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience
- Experience working in CRO industry preferred
- Working knowledge of CDMS/EDC systems and CDISC standards is a must
- Strong working knowledge of Clinical Research procedures and guidelines, required
- Extensive organizing and coordinating skills
- Solid understanding of clinical drug development is preferred
- Excellent organizational skills and attention to detail
- Strong written and verbal communication skills
- Technology proficiency including Data Management Systems
- Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality
- Strong computer skills, including Microsoft Office
- Ability to read, interpret, and understand documents and reports
Benefits
- medical and dental coverage
- matching 401(k)
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
EDC programmingCDMSCDISC standardsdata processingreport generationdashboard creationprogramming activitiesquality assurancedata management systemsclinical trial databases
Soft skills
organizational skillsattention to detailcommunication skillsleadershipcross-functional collaborationprocess improvementproblem-solvingtechnical guidancemonitoring project scopevendor relationship management
