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 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 in alignment with core business strategies, including forecasting costs, reviewing invoices, and assessing vendors to maintain budgetary alignment.

Day in the Life

Your work involves a dynamic mix of operational support, compliance, and data management. You will collaborate 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 establishing and overseeing the full lifecycle of sample management—from collection and processing to storage, shipping, and transfer.

You will partner closely with data management leads to define how sample and testing data are captured, blinded, and transferred for clinical trials. Additionally, you will provide guidance to clinical teams and sites regarding the proper handling of human samples, ensuring all collection and usage practices comply with study protocols and informed consent agreements. This includes working with internal teams to ensure all samples transferred to research groups are meticulously documented, tracked, and disposed of according to regulations.

Hiring Process

Qualified candidates will be evaluated based on their clinical research experience, specifically within academic, CRO, or pharmaceutical/biotech settings. The selection process focuses on identifying professionals with a strong working knowledge of clinical trials and databases, alongside the ability to resolve problems spontaneously and work independently.

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.