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 tangible medical applications.

In this capacity, you will partner closely with project managers from central and specialty labs, lending expertise to Clinical Trial Management (CTM) and Contract Research Organizations (CROs). Your focus will be on ensuring samples are collected strictly according to protocol and assisting in the resolution of any sample-related issues or queries. Beyond technical execution, the role involves overarching project management aligned with the core business strategy, requiring you to assess vendors, forecast operational costs and timelines, and review invoices to maintain budget alignment.

Day-to-Day Impact

Your work will span the entire lifecycle of sample management. You will establish, oversee, and integrate processes for the collection, processing, storage, shipping, and transfer of samples and data, including reporting and billing for study operations. You will collaborate with Informed Consent Form (ICF) specialists to ensure trial documents accurately reflect sample and testing requirements. Additionally, you will guide clinical teams and sites on the proper collection, storage, and shipping of human samples, ensuring compliance with study protocols and applicable ICFs. You will also work with internal teams to ensure all samples transferred to research groups are meticulously documented, tracked, utilized, and destroyed in accordance with regulations.

Hiring Process

Qualified candidates will be invited to participate in a structured interview process designed to assess both technical expertise and cultural fit. This typically includes an initial screening, followed by a deeper discussion on clinical trial management and sample logistics, and concludes with a team fit interview.

Our Culture & Commitment

Parexel is an equal opportunity employer. We are committed to fostering a diverse and inclusive environment where qualified applicants receive consideration for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. We value effective relationships across platform lines, Business Units, and Research Units to facilitate successful portfolio delivery.