Precision Medicine Group
Healthcare
ClinicalDataManagerII/SeniorClinicalDataManager
“Clinical Data Manager II/Senior Clinical Data Manager at Precision Medicine Group. Skills: Clinical data management, Database management, Project management. Manage clinical trial data management process. Oversee database development”
Industry & Context.
Troubleshoot operational problems
Occasional travel
What They're Looking For.
Must Have
8+ years experience as Sr. Clinical Data Manager, 5+ years experience as Clinical Data Manager II, Bachelors and/or related experience, Proficiency in Microsoft Office, Excellent organizational skills, Excellent communication skills, Professional use of English
Nice to Have
Oncology experience preferred, PhD preferred
What You'll Do.
Manage clinical trial data management process
Oversee database development
Oversee database testing
Serve as Primary Data Management contact
Oversee project data entry process
Develop data entry guidelines
Control data entry quality
Assess resource needs
Develop CRF specifications
Coordinate CRF specification review
Conduct database build UAT
Maintain database build documentation
Oversee clinical database quality
Specify edit check requirements
Oversee edit check specification development
Oversee manual data review specification development
Create data management documentation
Revise data management documentation
Version data management documentation
Maintain data management documentation
Oversee data management documentation completeness
Train clinical research personnel
Review clinical trial data
Query clinical trial data
Perform line listing data review
Run patient status reporting
Run study level reporting
Perform medical coding
Coordinate SAE reconciliation
Coordinate AE reconciliation
Liaise with third-party vendors
Assist with SAS programming
Quality control SAS programs
Identify operational problems
Troubleshoot operational issues
Troubleshoot operational obstacles
Troubleshoot operational barriers
Provide feedback on protocols
Provide feedback on SAP
Provide feedback on CSR
Participate in SOP development
Participate in process documentation development
Maintain process documentation
Attend strategy meetings
Attend bid defense prep meetings
Attend capability presentations
Attend client engagement meetings
Provide project estimates
Provide leadership for initiatives
Train data management team members
Ensure data management team training
Communicate with study sponsors
Communicate with vendors
Communicate with project teams
Present software demonstrations
Present software trainings
Present department training sessions
Present company training sessions
Present at project meetings
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional teams; Project teams; Study sponsors; Third-party vendors
Communication Scope
Written communication; Oral communication
Process & Methodology
Project management
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