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External Bioanalytical Monitor (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
294090/11
IHRE AUFGABEN:
-Working as a member of the bioanalytical outsourcing group within DMPK (Drug Metabolism and Pharmacokinetics)
-Coordinate and monitor bioanalytical activities outsourced to external partners
-Acting as the interface with the clinical teams
-Coordinate clinical sample analysis according to the study needs and timelines
-Perform quality checks of the bioanalytical data and reports before their release
-Support clinical teams in setting up the clinical trials by providing bioanalytical input on sample collection, bioanalytical method, bio-analytical data release
-Provide CROs with the required information to start their activities (study protocol, method description, timelines etc.)
-Monitor outsourced activities at CRO during the course of the studies
-Help CROs with trouble-shooting when required
-Review and release CRO data and reports
-Mediate and manage contact and communication with internal customers and external partners
IHRE QUALIFIKATIONEN:
-Profound experience in pharmaceutical industry or CRO
-Good background in bioanalytics for large molecules (familiar with regulatory guidelines for bioanalytics (GLP/GCLP) is of advantage)
-Experience in method development and technical trouble-shooting is of advantage
-Good communication skills to interact with people from different sectors and levels
-Fluency in English (oral and written)
-Basic understanding of outsourcing processes
-Demonstrated ability to work independently and to handle new assignments with minimal supervision
WEITERE QUALIFIKATIONEN:
R&D scientist
294090/11
IHRE AUFGABEN:
-Working as a member of the bioanalytical outsourcing group within DMPK (Drug Metabolism and Pharmacokinetics)
-Coordinate and monitor bioanalytical activities outsourced to external partners
-Acting as the interface with the clinical teams
-Coordinate clinical sample analysis according to the study needs and timelines
-Perform quality checks of the bioanalytical data and reports before their release
-Support clinical teams in setting up the clinical trials by providing bioanalytical input on sample collection, bioanalytical method, bio-analytical data release
-Provide CROs with the required information to start their activities (study protocol, method description, timelines etc.)
-Monitor outsourced activities at CRO during the course of the studies
-Help CROs with trouble-shooting when required
-Review and release CRO data and reports
-Mediate and manage contact and communication with internal customers and external partners
IHRE QUALIFIKATIONEN:
-Profound experience in pharmaceutical industry or CRO
-Good background in bioanalytics for large molecules (familiar with regulatory guidelines for bioanalytics (GLP/GCLP) is of advantage)
-Experience in method development and technical trouble-shooting is of advantage
-Good communication skills to interact with people from different sectors and levels
-Fluency in English (oral and written)
-Basic understanding of outsourcing processes
-Demonstrated ability to work independently and to handle new assignments with minimal supervision
WEITERE QUALIFIKATIONEN:
R&D scientist
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges