The Biomarker Samples Manager is an operational expert and accountable for all operational aspects associated with piloting, implementing and/or standardizing sampling methods and procedures
The Manager is an integral part of the Sample Management CoE and contributes to driving the methodology evolution from an exploratory phase to a standardization phase to support both biomarker research and clinical endpoints. The Manager is also responsible for training and/or implementing sampling methods in selected specialty labs and/or hospital.
• Responsible for implementing sampling methods and procedures to be performed by hospital site staff in clinical studies. You develop Lab Manual and Training Material for clinical trials ;
• Track and update the Lab Manual and other auxiliary material as appropriate and timely, such as Sample Data Sheets and Training Material.
• For commercially available sampling and processing methodologies, you are responsible for any necessary modification/customization in the Lab Manual to support the specific needs in in-scope clinical studies.
• Oversee and follow up with external lab service providers who develop/standardize sampling methods and/or execute procedures to ensure that the vendors have the appropriate infrastructure
• Oversee and follow up on the performance of sample management related vendors (e.g., timely delivery of high quality samples, sample meta-data and data reports) in clinical studies.
• Engage and instruct the local or central lab on the specific components of the translational sampling kits
• Provide input to budget forecast/accrual related to sample management in clinical studies, as requested.
• Assist in presentation of sampling methods and procedures You focus on the operational aspects of the sampling procedures at the training/meetings.
• Oversee and follow through the chain of custody of the collected samples in assigned studies.