PSI CRO
Biotech
LeadDataManagerforClinicalTrials
“Lead Data Manager for Clinical Trials at PSI CRO. Skills: Data management, Clinical trials. Coordinate data management activities. Develop EDC”
What You'll Achieve.
Database Lock; Final integrated database development; Generation of final Data Management deliverables
Industry & Context.
Data discrepancy resolution; Query resolution
What They're Looking For.
Must Have
College or University degree or equivalent combination of training and experience, At least 3 years of experience of full scope of data management responsibilities in global EDC studies, At least 2 years of experience using CDM/EDC systems
Nice to Have
Project data management experience is a plus, Medidata Rave or Oracle Inform preferable
What You'll Do.
Coordinate data management activities
Generate final Data Management deliverables
Review study documents
Develop Data Management plan
Develop project-specific guidelines
Review project-specific guidelines
Perform user acceptance testing
Develop Data Validation Plan
Develop Edit Check Specifications
Coordinate data entry
Provide feedback to data entry personnel
Review data discrepancies
Resolve data discrepancies
Provide feedback to clinical trial teams
Handle non-CRF electronic data
Receive non-CRF electronic data
Archive non-CRF electronic data
Load non-CRF electronic data
Review non-CRF electronic data reconciliation issues
Resolve non-CRF electronic data reconciliation issues
Provide feedback to vendors
Perform database edits
Perform manual CRF review
Lock clinical database
Coordinate CRF processing
Supervise CRF processing
Coordinate query processing
Supervise query processing
Input into design of CRFs
Design CRFs for accuracy
Ensure adherence to protocol
Develop CRF completion guidelines
Review coding listings
Perform SAE reconciliation
Review electronic data transfer specifications
Approve electronic data transfer specifications
Liaise with Document Center
Perform Database QC checks
Document Database QC checks
Prepare for inspections
Follow up on audit findings
Resolve audit findings
Train Assistant Data Managers
Provide project-specific training
Train investigators on CRF completion
Train clinical team on CRF completion
Prepare Investigator Meetings
Attend Investigator Meetings
Prepare for client meetings
Attend client meetings
Prepare for vendor teleconferences
Attend vendor teleconferences
How You'll Work.
Team & Collaboration
Project teams; Company departments; Clients; Vendors; Clinical teams
Communication Scope
Client communication; Vendor communication
Process & Methodology
Project data management
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