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 (DM), 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.

You will act as a key liaison between project managers, central and specialty labs, and Clinical Trial Management (CTM) teams. Your expertise will be essential in guiding Clinical Research Organizations (CROs) to ensure sample collection strictly adheres to study protocols. Beyond technical oversight, you will manage operational aspects of the project, aligning daily activities with the core business strategy to resolve sample-related queries and issues efficiently.

Day in the Life

Your work involves a dynamic mix of operational support, data management, and compliance. You will support individual clinical study teams by addressing technical and operational sample-related matters, often collaborating with Informed Consent Form (ICF) specialists to ensure trial documents accurately reflect sample and testing requirements.

A significant portion of your time will be dedicated to the lifecycle of sample analysis. This includes establishing and overseeing the planning, collection, processing, storage, shipping, and transfer of samples and data. You will also manage the reporting and billing for these study-related operations. On the data front, you will partner closely with data management leads to define how sample and testing data are captured, blinded, and transferred for clinical trials.

You will provide expert guidance to clinical teams and sites regarding the collection, storage, and shipping of human samples. Ensuring compliance is a daily priority; you will work with scientists and clinical teams to verify that sample collection and usage align with study protocols and applicable ICFs. Additionally, you will coordinate with the internal Human Sample Management team to ensure all samples transferred to internal research groups are meticulously documented, tracked, utilized, and destroyed according to protocol.

Hiring Process & Application

Qualified candidates with 6 to 8 years of clinical research experience in academic, CRO, or pharmaceutical/biotech industries are encouraged to apply. While laboratory sample management experience is a plus, a working knowledge of clinical trials and clinical databases is essential. Please note that this is a remote position.

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 effective portfolio delivery.