Clinical Laboratory Study Manager - FSP

About the Role

The Clinical Laboratory Study Manager serves as a strategic bridge between science and execution, working closely with the Precision Medicine Strategy Lead, clinical study teams, and specialized groups including Data Management (DM), Samples, Kits, Data, Logistics (SKDL), and Clinical Laboratory Project Management (CLPM). The core mission of this position is to ensure the delivery of high-quality samples and data that support both biomarker and non-biomarker evaluations, ultimately enabling the translation of scientific discoveries into effective medicines.

In this role, you will oversee the entire lifecycle of clinical sample management, from collection and chain of custody to usage per informed consent forms, tracking, and final destruction. You will act as a key liaison between internal stakeholders and external vendors, managing central and specialty laboratories to ensure samples are collected strictly according to protocol. Your expertise will be critical in resolving sample-related queries, supporting Clinical Trial Management (CTM) and CROs, and aligning project execution with the broader business strategy.

Day in the Life

Your work involves active participation in cross-functional study teams, collaborating with project managers and set-up teams to build robust lab databases that address specific clinical trial needs for kits, testing, and logistics. You will monitor the acquisition and testing of diverse sample types, including human tissue, whole blood, plasma, and serum, while providing technical and operational guidance to clinical sites.

A significant portion of your time will be dedicated to operational oversight, including the planning and integration of sample collection, processing, storage, shipping, and data transfer. You will assess vendors, forecast operational costs, review invoices, and prepare RFPs to ensure alignment with budget plans. Additionally, you will guide the development of data transfer specifications in collaboration with data management leads to ensure sample and testing data are captured, blinded, and transferred correctly for clinical trials.

Hiring Process

Qualified candidates will be considered for this remote position. The selection process focuses on identifying individuals with strong project management capabilities and deep industry experience who can work independently while contributing effectively to group initiatives.

Equal Opportunity

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.