Clinical Biospecimen Scientist
Posted Aug 4
Posted Aug 4
This is a fully remote position, open to applicants in United Kingdom, +3 more states.
• Provide insights on the clinical sample assessment sections within clinical trial documents, such as protocols and consents.
• Develop study-specific tables for sample collection and ensure alignment of required blood volumes with permissible limits.
• Collaborate with internal stakeholders to inform on safety and pharmacokinetic sample collection and testing requirements.
• Establish and manage the technical components of laboratories responsible for kit assembly, sample management, and testing procedures.
• Oversee the maintenance of laboratory documentation, including lab manuals.
• Offer input and solutions regarding ethical considerations in biospecimen collection and analysis.
• Oversee sample management and logistics under the guidance of the Lead CBS.
• Work closely with the Lead CBS to address trial-specific risks and issues related to biospecimen collection and analysis.
• Be fully integrated within a dynamic, global healthcare organization.
• Execute and implement the GCO clinical study strategy for designated biospecimen samples.
• Prior experience with a CRO or vendor.
• Experience in managing human samples, beyond just in-vitro or animal testing management.
• Knowledge of clinical sample assessments and their requirements.
• Familiarity with laboratory design from the perspective of clinical trial protocols.
• Experience with central laboratory systems, laboratory constructions, and data transfer specifications.
• A degree in a relevant scientific field.
• Laboratory experience in sample management and processing.
• Understanding of assay requirements for samples involved in assigned studies.
• Experience in kit design and protocol development.
• Strong communication skills across various departments and functions.
• Knowledge of biospecimen collection requirements, sampling timepoints, and data analysis.
• Legal eligibility to work in the country where the position is located.
• Competitive base salary along with performance-based incentives.
• Health and wellness programs, including medical, dental, and vision insurance where applicable.
• Retirement and pension plans.
• Life insurance and disability coverage.
• Employee assistance programs and wellness resources.
• Opportunities for learning and development through structured training and career pathways.
• Reasonable accommodations provided during the recruitment process.
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