PSI CRO AG ยท 20 hours ago
Lead Data Manager
United States
Full-time
Remote
Senior Level
3+ years exp
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Responsibilities
Acts as primary communication point for project teams and company departments regarding clinical data management
Acts as primary communication point for clients/vendors for all data management aspects of clinical projects
Coordinates data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables
Provides input into monitoring of project scope, budget, timelines, and deliverables
Is responsible for clinical data management activities including, but not limited to: Development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable)
User acceptance testing
User access management
Data review
ECRF/External data reconciliation
Medical coding (for staff with medical/Life Science background)
SAE reconciliation
Query management
Study Database Lock activities
Archival of CRFs QC Coordination
Project status reporting
Data listings/Patient profiles generation
Maintains and QCs TMF/eTMF as well as Data Management working files
Trains Data Managers and Assistant Data Manager
Conducts project-specific training
Qualification
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Required
College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities
Minimum of three years of industry experience in Data Management
Two years in Data Manager role
This role requires travel on an as needed basis for client presentations, bid defense meetings, department meetings, and the like.
Company
PSI CRO AG
PSI is a leading global full service contract research organization that predictably enrolls patients across multiple therapeutic areas.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Juviler
Director Data Science
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