Clinical Biospecimen Scientist

Location - UK, Poland, Spain and Bulgaria

Fully sponsor dedicated

Working fully embedded within a growing, global healthcare company, you will be responsible, with appropriate oversight from the Lead CBS, for the implementation and end-to-end operational execution of each GCO clinical study strategy as it relates to selected biospecimens samples.

Accountabilities

• Contribute to providing input on clinical sample assessment sections in clinical trial-related documents (such as protocols and consents)

• Create study-specific sample collection tables and ensure alignment with blood volumes needed versus allowed.

• Liaise with internal stakeholders to provide input into the SSWs for safety and PK sample collection and testing needs.

• Responsible to set up and oversee the technical aspects of all laboratories involved in kit building, sample management and testing, including all related documentation such as lab manuals.

• Contribute to providing input and solutions on the ethical considerations for biospecimen collections and analyses for protocols and consents

• Responsible for sample management and logistics with appropriate oversight from the Lead CBS

Risk Management

• In collaboration with the Lead CBS, ensure proper escalation of any identified trial specific risks and issues related to biospecimen collection and analysis in conjunction with relevant line functions.

Job requirements:

• Previous CRO or vendor experience.

• Must have human sample management, not just in-vitro sample management or animal testing management.

• Must have an understanding of providing input on clinical sample assessments and requirements.

• Must have a background in understanding the design of a lab from the trial protocol perspective and would need to have systems experiences with the central labs to understand the build as well as Data transfer specification.

• Education: Science degree

• Lab background in terms of sample management, sample processing, understanding the assay requirements for the samples required for the assigned study. Kit design and protocol contribution

• Must be open and able to communicate across multiple departments and line functions.

• Biospecimen management: Understand the requirement of collection of samples and which timepoints they are collected/ analyzed and data is analyzed