Clinical Laboratory Study Manager - FSP

About the Role

This position serves as a critical bridge between scientific strategy and clinical execution. Working alongside the Precision Medicine Strategy Lead, clinical study teams, and specialized groups such as Data Management, Samples, Kits, Data, Logistics (SKDL), and Clinical Laboratory Project Management (CLPM), the role ensures the delivery of high-quality samples and data. The primary mission is to support biomarker and non-biomarker evaluations, enabling the translation of scientific discoveries into practical medicine.

In this capacity, you will partner closely with project managers from central and specialty labs, as well as Clinical Trial Management (CTM) and Contract Research Organizations (CROs). Your expertise will be essential in ensuring samples are collected strictly according to protocol and in assisting with the resolution of any sample-related issues or queries. Beyond technical execution, the role involves overarching project management aligned with the core business strategy.

Day-to-Day Impact

Your work will span the entire lifecycle of sample management. You will provide technical and operational support to clinical study teams, liaising with internal stakeholders such as Informed Consent Form (ICF) specialists to manage trial documents impacting samples and testing. You will establish, oversee, and plan the collection, processing, storage, shipping, and transfer of samples and data, while also managing reporting and billing for study operations.

Collaboration with Precision Medicine Strategy Leads and scientists will involve assessing vendors, forecasting operational costs and timelines, and reviewing invoices to ensure budget alignment. You will also work closely with data management leads to define how sample and testing data are captured, blinded, and transferred for clinical trials. Furthermore, you will guide clinical teams and sites on the proper collection, storage, and shipping of samples, ensuring compliance with study protocols and applicable ICFs. You will also coordinate with the internal Human Sample Management team to ensure all samples transferred to research groups are accurately documented, tracked, utilized, and destroyed.

Joining Parexel

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. We are committed to maintaining effective relationships across platform lines, Business Units, and Research Units to facilitate effective portfolio delivery.

Application Instructions

Candidates must possess a Bachelor's degree in a life science, nursing qualification, or other relevant experience. This role is remote (indicated by #LI-REMOTE) and requires 6-8 years of clinical research experience within academic, CRO, or pharmaceutical/biotech industries. While laboratory sample management experience is a plus, the core requirement is a working knowledge of clinical trials and clinical databases. Please ensure your CV is up to date as part of the application process.