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.

You will act as a subject matter expert for project managers and CROs, ensuring sample collection strictly adheres to study protocols. Beyond technical oversight, you will manage operational aspects including the establishment and integration of sample collection, processing, storage, shipping, and transfer workflows. This includes forecasting operational costs, reviewing invoices for budget alignment, and collaborating with data management leads to determine how sample and testing data are captured, blinded, and transferred for clinical trials.

A key component of the day-to-day involves guiding clinical teams and sites on the compliant collection, storage, and shipping of human samples. You will ensure all sample usage aligns with study protocols and Informed Consent Forms (ICF), while maintaining rigorous documentation and tracking for samples transferred to internal research groups.

Hiring Process

Qualified candidates will be evaluated based on their clinical research background and ability to navigate complex operational landscapes. The selection process typically involves reviewing relevant experience in academic, CRO, or pharmaceutical/biotech settings, with a strong emphasis on laboratory sample management knowledge.

Culture & Equal Opportunity

Parexel fosters an environment where effective relationships across platform lines, Business Units, and Research Units are essential for portfolio delivery. We value professionals who can work independently and proactively while contributing to group initiatives.

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.