Clinical Biospecimen Scientist (East Coast)

Overview

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.

Responsibilities

What you will be doing:

• 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).
• 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.

Qualifications

You are:

• Advanced degree in life sciences strongly preferred, BS or BA in life sciences with relevant experience required
• Familiarity with standard sample testing methodologies, assay technologies, and molecular biology
• At least 2 years of experience handling diverse type of clinical samples
• Knowledge of GCP; intermediate knowledge of GLP and ICH
• Intermediate knowledge of clinical trial design and the overall drug development process
• Excellent organizational and communication skills
• Ability to manage multiple competing priorities and meet timelines

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase sc