Responsible for the end-to-end execution of the biospecimen strategy for the Global Clinical Operations supported clinical studies.,
* For each clinical study, provide input and solutions for all biospecimen logistics and analysis, considering all ethical and regulatory requirements.
* Collaborate with strategic partners to enable implementation of each biospecimen strategy.
* Collaborate with internal project team in areas of end-to-end risk, relationship and issue management related to biospecimen collection and analysis.
* Collaborate with TDM for eCRF development, data transfer and reconciliation ensuring timely analysis, proper consent, and oversight of all biospecimens
Deliverables
* Study specific sample collection and analysis plan.
* Lab kits and training materials on the technical aspects of biospecimen collections for the clinical trial sites.
* Ensure analysis and data transfers per study requirements
High problem solving, influencing, and negotiation skills
* Leadership skills in a matrix environment, with multi-disciplinary and networked teams
* Understanding clinical sample testing methods
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