FGK Clinical Research GmbH
Clinical Data Manager(m/w/x)
Full-timeWith HomeofficeExperienced
München, Berlin
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PSPSI CRO
Principal Lead Data Manager(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
End-to-end supervision of EDC development and data cleaning for clinical trials at a global CRO. Five years of industry experience as a Lead Data Manager required. Coordination of 5+ cross-functional departments and external vendors.
Requirements
- College degree, University degree, or equivalent training and experience
- Five years of CRO industry experience as Lead Data Manager or equivalent
- Three years of experience using CDM/EDC systems
- Project data management experience is a plus
- Full working proficiency in English
- English language skills
- Organizational and managerial skills
Tasks
- Act as primary contact for project teams and departments
- Lead communication with clients and vendors on data management
- Supervise all project data management activities for assigned studies
- Coordinate EDC development and data collection
- Manage data cleaning and reconciliation processes
- Oversee Database Lock activities and final integrated database development
- Generate final Data Management deliverables
- Monitor project scope, budget, timelines, and deliverables
- Develop comprehensive study documentation
- Perform User Acceptance Testing and manage user access
- Conduct data reviews and eCRF or external data reconciliation
- Perform SAE reconciliation and manage queries
- Coordinate QC and archive CRFs
- Report on project status and deliver data listings
- Maintain and quality control the eTMF
- Maintain and quality control Data Management working files
- Prepare for and attend internal and third-party audits
- Resolve audit findings related to Data Management
- Train Lead, Data, and Assistant Data Managers
- Conduct project-specific CRF completion training for clinical teams
- Present at Investigator Meetings
- Provide input for proposals and business development activities
- Participate in corporate and departmental process improvement
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CDM
- EDC
- Medidata Rave
- Oracle Inform
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PSI CRO and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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PSPSI CRO
Principal Lead Data Manager(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
End-to-end supervision of EDC development and data cleaning for clinical trials at a global CRO. Five years of industry experience as a Lead Data Manager required. Coordination of 5+ cross-functional departments and external vendors.
Requirements
- College degree, University degree, or equivalent training and experience
- Five years of CRO industry experience as Lead Data Manager or equivalent
- Three years of experience using CDM/EDC systems
- Project data management experience is a plus
- Full working proficiency in English
- English language skills
- Organizational and managerial skills
Tasks
- Act as primary contact for project teams and departments
- Lead communication with clients and vendors on data management
- Supervise all project data management activities for assigned studies
- Coordinate EDC development and data collection
- Manage data cleaning and reconciliation processes
- Oversee Database Lock activities and final integrated database development
- Generate final Data Management deliverables
- Monitor project scope, budget, timelines, and deliverables
- Develop comprehensive study documentation
- Perform User Acceptance Testing and manage user access
- Conduct data reviews and eCRF or external data reconciliation
- Perform SAE reconciliation and manage queries
- Coordinate QC and archive CRFs
- Report on project status and deliver data listings
- Maintain and quality control the eTMF
- Maintain and quality control Data Management working files
- Prepare for and attend internal and third-party audits
- Resolve audit findings related to Data Management
- Train Lead, Data, and Assistant Data Managers
- Conduct project-specific CRF completion training for clinical teams
- Present at Investigator Meetings
- Provide input for proposals and business development activities
- Participate in corporate and departmental process improvement
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CDM
- EDC
- Medidata Rave
- Oracle Inform
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PSI CRO and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
PSI CRO
Industry
Pharmaceuticals
Description
The company is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation.
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