External Bioanalytical Monitor (m/f)

Description

• 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

• 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