PSI CRO
Biotech
LeadDataManagerforClinicalTrials
Neural analysis suggests this role is
optimal for mid candidates.
“Lead Data Manager for Clinical Trials at PSI CRO. Skills: Data management, Clinical trials, EDC systems. Manage data management activities. Serve as communication point”
Industry & Context.
Data validation; Data cleaning; Data reconciliation
What They're Looking For.
Must Have
College or University degree, 3 years of experience, 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.
Manage data management activities
Serve as communication point
Coordinate data management activities
Develop study documents
Develop data management plans
Review project guidelines
Perform user acceptance testing
Develop data validation plans
Develop edit check specifications
Coordinate data entry
Provide feedback on data entry
Perform data validation
Review data discrepancies
Resolve data discrepancies
Provide feedback on data quality
Handle non-CRF electronic data
Archive electronic data
Review reconciliation issues
Provide feedback to vendors
Perform database edits
Perform clinical database lock
Coordinate CRF processing
Develop CRF guidelines
Review coding listings
Perform SAE reconciliation
Review data transfer specifications
Approve data transfer specifications
Liaise with Document Center
Perform database QC checks
Resolve audit findings
Train Assistant Data Managers
Provide project-specific training
Prepare investigator meetings
Attend investigator meetings
Prepare client meetings
Attend client meetings
Prepare vendor meetings
Attend vendor meetings
How You'll Work.
Team & Collaboration
Project teams; Company departments; Clients; Vendors; Clinical teams
Communication Scope
Client communication; Vendor communication; Project communication
Process & Methodology
Project management
Full Job Description
We’re over 3,200+ strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way. The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects. Communication * Primary communication point for project teams and company departments with regard to clinical data management * Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting Data Management * Coordination of 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. * Primary responsibility for clinical data management activities within clinical projects, including, but not limited to: * Study documents review * Data Management plan and other project-specific guidelines and instructions development and review * Co-ordinate/perform user acceptance testing * Development of Data Validation Plan/Edit Check Specifications * Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues * Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data * Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues) * Database edits (paper CRF
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