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Clinical Data Processing Project Manager
Eingestellt von IT Human Resources
Gesuchte Skills: Support, Client
Projektbeschreibung
CLINICAL DATA PROCESSING PROJECT MANAGER
My client, an international pharmaceutical group, is looking to recruit a Clinical Data Processing Project Manager for a contract of 6 months based in Belgium.
This position is part of the clinical data processing solution (DPS) team. The platform is based on SAS Drug Development (SDD) and a custom application to deliver the user community (data managers and programmers of clinical studies) with an integrated process for study data validation as well as additional tooling's for specific data conversions and data validation.
In 2016 a project is planned to execute clinical trial migrations from an internal file server based infrastructure towards an externally hosted cloud solution based on SAS Drug Development. Next to data (clinical data, outputs and additional files related to the data), SAS programs will be migrated to the new environment as well. Most of these migration executions will be outsourced as a service but needs to be coordinated from within the DPS team.
The successful Clinical Data Processing Project Manager candidate will be part of the DPS team and be responsible for the coordination, planning and execution of the study migration project on a daily basis. Achieving completion of the project by yearend 2016 is a high priority for the organization.
The successful Clinical Data Processing Project Manager candidate will have the following responsibilities:
* Overall and detailed planning is key for this project.
. Manage the workload for internal and external resources.
. Work closely together with all stakeholders (IDAR, SAS developers, CRO personnel, management, ) and get them acquainted with the changing process (organizing trainings, Q&A sessions, meetings, ad-hoc support ).
. Check and review completion of test scripts on a trial basis in the HP Application Lifecycle Management tool (HP ALM) to keep an oversight of the quality of the migration activities and the results.
. Create dashboards and metrics to keep track of project on a daily basis and report these figures to our management on a regular basis.
. Report on a quarterly basis about the project progression via a QA summary report.
. Support audit and inspections as appropriate.
. The services will be performed within the framework of GXP guidelines like system validation
The ideal Clinical Data Processing Project Manager will have the following Education, Experience and Qualifications:
- Minimal Bachelor degree in statistics, computer science or related
. Experience with HP ALM would be strong plus
. Experience with SAS and SAS drug development knowledge would be a plus
. Knowledge and/or experience with Pharma R we welcome applicants from all backgrounds.
My client, an international pharmaceutical group, is looking to recruit a Clinical Data Processing Project Manager for a contract of 6 months based in Belgium.
This position is part of the clinical data processing solution (DPS) team. The platform is based on SAS Drug Development (SDD) and a custom application to deliver the user community (data managers and programmers of clinical studies) with an integrated process for study data validation as well as additional tooling's for specific data conversions and data validation.
In 2016 a project is planned to execute clinical trial migrations from an internal file server based infrastructure towards an externally hosted cloud solution based on SAS Drug Development. Next to data (clinical data, outputs and additional files related to the data), SAS programs will be migrated to the new environment as well. Most of these migration executions will be outsourced as a service but needs to be coordinated from within the DPS team.
The successful Clinical Data Processing Project Manager candidate will be part of the DPS team and be responsible for the coordination, planning and execution of the study migration project on a daily basis. Achieving completion of the project by yearend 2016 is a high priority for the organization.
The successful Clinical Data Processing Project Manager candidate will have the following responsibilities:
* Overall and detailed planning is key for this project.
. Manage the workload for internal and external resources.
. Work closely together with all stakeholders (IDAR, SAS developers, CRO personnel, management, ) and get them acquainted with the changing process (organizing trainings, Q&A sessions, meetings, ad-hoc support ).
. Check and review completion of test scripts on a trial basis in the HP Application Lifecycle Management tool (HP ALM) to keep an oversight of the quality of the migration activities and the results.
. Create dashboards and metrics to keep track of project on a daily basis and report these figures to our management on a regular basis.
. Report on a quarterly basis about the project progression via a QA summary report.
. Support audit and inspections as appropriate.
. The services will be performed within the framework of GXP guidelines like system validation
The ideal Clinical Data Processing Project Manager will have the following Education, Experience and Qualifications:
- Minimal Bachelor degree in statistics, computer science or related
. Experience with HP ALM would be strong plus
. Experience with SAS and SAS drug development knowledge would be a plus
. Knowledge and/or experience with Pharma R we welcome applicants from all backgrounds.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges