The Biomarker Operations Project Manager has to plan, coordinate and oversee all operational activities required to manage the lifecycle of biosamples (including collection, processing, analysis, data receipt and final repository) of non-safety samples in a clinical study. The BOPM has to provide Biomarker operational expertise to the SMT to one or more cross-functional global studies.
The primary responsibilities:-
Provide input during protocol and ICF development to ensure logistical feasibility of biological sampling in alignment with ICH/GCP, appropriate policies, procedures and samples testing plans
Determine timelines and request the type of internal resource needed for all biosample operational activities
Write the Biosample Management Plan, a functional deliverable to the SMT, to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type and contribute to the development of biomarker-related plans
Ensure the investigator sites and/or central labs send samples according to agreed stability shipping schedule for the study and take corrective action where necessary.
Oversee vendors for the duration of the contract to ensure samples are received, assayed, and data is reported according to study timelines
Review and approval of invoices (as needed) in financial systems to ensure appropriate work has been completed
Responsible for monitoring effectiveness of investigator site sample handling training and quality of samples received and take corrective action as necessary
Life science degree or equivalent experience (Clinical Coordinator/Clinical Research Scientist background - preferably pharma industry)
Proven clinical development experience working in teams running clinical studies, site monitoring or working in clinical studies at an investigator site
Experience in leading initiatives/projects
Vendor management experience is advantageous
Specific Oncology TA experience is preferable but not essential
Proven critical reasoning skills including the identification and resolution of complex problems
This is a great opportunity to work with one of the top pharmaceutical companies in the Life science industry. If you believe this is a position you can thrive in, send through your updated CV to Callum.McConnochie@HobsonPrior.com