Supports Data Management in meeting technical deliverables for studies and creating and providing technical solutions to enable efficient processes
Uses expertise in primary development tools within Data Operations
Supports development of specifications for technical data management processes and systems
Contribute to the Request For Proposal (RFP) and Request for Information (RFI) process
Prepares input for proposal bid defense meetings where appropriate
Acts as Subject Matter Experts (SME) for designated systems/databases used by Data Management (DM)
Assists with developing, monitoring and enforcing productivity, quality standards and efficiencies, input into the development of project and timeline metrics
Participates in and supports internal and external audits and inspections
Develops and/or delivers applicable data management departmental training related to technical processes and systems
Supports the development of CRF and eCRF completion guidelines
Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date
Requirements
Bachelor’s degree, Master’s degree preferred, or RN
Good ability to explain technical processes
Experience with EDC Build in Setup, (Writing specification, Performing UAT, Writing Listings, understanding of protocol, understanding of Architect)
EDC: Rave / Veeva
Good organizational, planning and time management skills
Ability to multitask to deliver to tight deadlines while providing attention to detail
Ability to be flexible and adapt to change, working independently and as part of a global multi-disciplinary team
Knowledge of ICH/GCP regulatory requirements for clinical studies
Benefits
Health insurance
Professional development opportunities
Total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
EDC BuildWriting specificationPerforming UATWriting ListingsUnderstanding of protocolUnderstanding of Architect
Soft skills
Ability to explain technical processesOrganizational skillsPlanning skillsTime management skillsAbility to multitaskAttention to detailFlexibilityAdaptabilityIndependenceTeam collaboration