Description
Role Overview: The position plans and coordinates all operational activities required throughout the whole lifecycle of samples, including collection, processing, analysis, data transfer, and final repository of non-safety samples within a clinical study. The role is simultaneously assigned to multiple studies. The position provides sample management expertise and may also participate in Biomarker and Pharmacology teams. In addition, the role is accountable for ensuring that samples collected are of good analysable quality and are collected in adherence to the highest standards of ethics and informed consent. The role is the primary interface for operational activities between the teams and laboratories performing biomarker or PK analysis.Responsibilities:
- Accountable for planning, organising and overseeing the collection and shipping of biosamples from investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analysable quality
- Accountable for accurately forecasting and tracking study biosample costs related to materials, logistics and shipping when the CSO (Clinical Sample Operations) is the point of first receipt for the samples
- Determine timelines and request the type of internal resource needed for all biosample operational activities, ensuring these are included in study plans and are appropriately tracked
- Provides the day-to-day operational management of CROs (i.e. central lab, etc.) and biomarker assay vendors to ensure deliveryagainst contracted scope of work, including coordination of scope of work development, performance management, and issue resolution
- Accountable for ensuring suitable sample handling training and sample collection and processing reference material are provided to the investigator sites, study monitors/CRO partners
Requirements:
- Life Sciences degree
- Proven clinical development experience of working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator sites
- Proven clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
- Vendor Management experience advantageous
- Detail oriented with the ability to work independently and manage multiple competing priorities
To find out more about Real please visit www.realstaffing.com