Parexel are currently recruiting for an experienced Central Labs Project Manager to immediately join one of our key sponsors in Europe, based in the UK you will be working on global studies.
You will be responsible for ensuring that quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine.
You will 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. Additional responsibilities include overall project management in alignment with the core business strategy.
Responsibilities
- Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing
- 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.
- Provides 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.
- Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF.
- Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed.
Requirements
- 6-8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a professional with 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.
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