Precision Medicine Group
ClinicalDataManagerII/SeniorClinicalDataManager
“Clinical Data Manager II/Senior Clinical Data Manager at Precision Medicine Group. Skills: Clinical data management, Database management, Data quality control. Manage clinical trial data management process. Oversee database development”
What You'll Achieve.
Meet deadlines with quality
Industry & Context.
Troubleshoot operational problems
Occasional travel
What They're Looking For.
Must Have
Bachelors and/or related experience, 8+ years Sr. Clinical Data Manager experience, 5 years Clinical Data Manager II experience, Proficiency in Microsoft Office, English proficiency (written and oral)
Nice to Have
PhD preferred, Experience in clinical, scientific or healthcare discipline, Dictionary medical coding experience, Understanding of CDISC standards, Oncology therapeutic experience, Orphan Drug therapeutic experience
What You'll Do.
Manage clinical trial data management process
Oversee database development
Oversee database testing
Serve as Primary Data Management contact
Ensure task continuity and responsiveness
Support another Lead DM
Oversee project data entry process
Develop data entry guidelines
Manage data entry quality
Assess resource needs
Develop CRF specifications
Coordinate CRF specification review
Build clinical databases
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 documentation completeness for TMF
Train personnel on CRF
Train personnel on EDC
Review clinical trial data
Query clinical trial data
Perform line listing data review
Run patient status reporting
Run study status reporting
Perform medical coding
Coordinate SAE reconciliation
Coordinate AE reconciliation
Liaise with third-party vendors
Assist with SAS programming
Perform SAS programming quality control
Identify operational problems
Troubleshoot operational issues
Troubleshoot operational obstacles
Troubleshoot operational barriers
Provide feedback on protocols
Provide feedback on SAP
Provide feedback on CSRs
Participate in SOP development
Participate in SOP maintenance
Participate in process documentation development
Participate in process documentation maintenance
Attend strategy meetings
Attend bid defense prep meetings
Attend capability presentations
Attend potential client engagement meetings
Provide project estimates
Provide leadership for initiatives
Train data management team members
Ensure team member 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; Vendors
Communication Scope
Oral communication; Written communication
Process & Methodology
Project management
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