Clinical Trial Manager - Central Laboratory Vendor Manager - Remote

New

Europe, based in the UKFull-TimeManager

Salary not disclosed

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Job Details

Experience: 6 - 8 years

Requirements

6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry
Working knowledge of clinical trials and clinical databases
Central Laboratory Management experience is essential
Oncology experience is mandatory, preference is for solid tumours, Haemato-oncology experience is fine, as long as oncology experience is solid, traceable; multiple phase experience (I to III)
Vendor coordination experience (e.g. Central Lab, specialty lab, CROs, etc)
Prior experience supporting clinical trials from set-up (ICF review/drafting for samples section, Protocol review for samples section, blood volume calculations, lab kit build), to initiation, maintenance and study close-out

Responsibilities

Ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine
Work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries
Overall project management in alignment with the core business strategy
Support individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders
Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations
Provide guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects
Work with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF
Work closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed

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