Biospecimen Scientist

Ttile: Biospecimen Scientist 

Location: EMEA wide - homebased 

Fully sponsor dedicated 

As a Biospecimen Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Job Purpose – 

Responsible for the implementation and end-to-end operational execution of each GCO clinical trial strategy as it relates to all biospecimens collected, including safety, pharmacokinetics, biomarkers, and companion diagnostics, in compliance with our clients process and regulatory and ethical requirements.

Accountabilities- 

With oversight from the Clinical Biospecimen Lead Scientist, contribute to all technical and operational biospecimen-related matters for assigned projects in collaboration with internal stakeholders and line function (LF) representatives.

• Provide input on clinical sample assessment sections in clinical trial-related document (such as protocols and consents) in collaboration with the LF representative.
• Create study-specific sample collection tables and ensure alignment with blood volumes needed versus allowed.
• Liaise with internal stakeholders to provide input into the SSW’s for all biospecimen collection and testing needs.
• Responsible to set up and oversee the technical aspects for all laboratories involved in kit building, sample management, and testing, including all related document such as lab manuals.
• Provide input and solutions on the ethical considerations for biospecimen collections and analysis for protocols and consents to ensure that all specific processes needed for approval in different countries are implemented.
• Responsible for sample management and logistics throughout the biospecimen lifecycle; this includes ensuring timely analysis, proper consent, and oversight of samples, in collaboration with data management.
• Define sample needs for the case report form (CRFs) and data transfer in collaboration with internal stakeholders/LF representatives, trial data manager (TDM) and analysis labs; With support, liaise with the TDM and labs for data transfer and data reconciliation.
• Collaborate with internal stakeholders to establish analytical plans and review transferred data to ensure quality.
• Develop training material on the technical aspects of biospecimen collections for the clinical trial sites, including study specific lab manuals and additional site and monitor trainings needs.
• Ensure proper handling of all study close out activities related to biospecimens and laboratories, including sample disposition (disposal, return, storage).
• In collaboration with EDO/vendor management, manage relationships with labs.

Risk management:

• In collaboration with EDO/vendor management, manage relationships with labs.
• Ensure proper escalation of any identified trial specific risks and issues related to biospecimen collection and analysis in conjunction with relevant line functions.

Resource management:

• In collaboration with vendor management and procurement, review all laboratory proposals and provide budget input for the trial forecast, review invoices.
• Responsible for implementation of and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and Development Unit, including sharing lessons learned.

• Activities & Interfaces – How does this role operate within, interact with, and impact the organization?

1. Collaborate with EDO/vendor management on oversight of all labs.
2. Collaborate with internal stakeholders to understand biospecimen strategy; this includes Clinical Development, Precision Medicine, and NIBR.
3. Key member of study team to ensure biospecimens are collected, analyzed, and data transferred as per the clinical protocol.

Key Performance Indicators- 

1. Adherence to GCO processes, SOPs, and ICH/GCP
2. Successful interactions in a matrix environment, getting input from internal stakeholders and the clinical teams to implement the sample logistics within the required timelines.
3. Prepare or contribute to study specific documents within established timelines.
4. Facilitate timely transportation of samples with appropriate annotation to analysis labs to ensure timely delivery of data.
5. Timely, efficient, and quality execution of biospecimen related activities for assigned clinical trials.
6. Proactive operational planning with effective contingency and risk mitigation plans.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.