A Clinical Biosample Project Manager is required for our client who provide consultancy and project management services in appraising the intended biomarker analytes, evaluating them for their clinical use and utility and managing the generation of relevant analytical data. You will be responsible for ensuring strategic operational input into clinical laboratory testing of human biological specimens and the efficient operational deployment of such clinical laboratory testing at the programme level (including biomarkers, central safety testing and clinical bioanalysis for pharmacokinetic assessment).
Key Duties and Responsibilities:
Provide appropriate contribution to the inclusion of laboratory testing of human biological specimens into clinical programmes and trials
Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of clinical biosamples (including companion diagnostic samples) - collection, processing, analysis, data delivery process and final sample disposition
Ensure all the laboratory components within planning operational delivery documents are accurate and fit for purpose. Ensuring strategy for the sampling plan is deployed and lessons learnt are communicated to the study level personnel to ensure optimal synergies of activities for study level activities in assigned projects
Collaboration with Biomarker scientists as well as operational teams, diagnostic partners, external CRO & Central Labs, and biomarker vendors to execute the biosample operational strategies on one or multiple studies/projects
Management of the development and oversight of the biosample analysis timelines, budget, risk, and quality plans
Oversee delivery of laboratory services and data from external providers at a project level.
Provide rapid, regular and frequent updates of all activities to the clinical study teams.
Key skillset / experience required:
Proven experience in clinical development and operational deployment of biological assays obtained in a major pharmaceutical company or large CRO organisation within a project management role is required.
Proven experience in oversight of external partners, laboratory service providers is required.
Biological laboratory experience and biomarker scientific background is desirable.