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) or CRO partners. Your expertise will be essential in ensuring samples are collected strictly according to protocol and in resolving any sample-related issues or queries that arise. Beyond technical oversight, you will drive overall project management aligned with the core business strategy, ensuring seamless operational flow from sample collection to data transfer.

Day in the Life

Your work involves a dynamic mix of operational support, compliance, and strategic planning. You will support individual clinical study teams by handling all 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 establishment and oversight of sample analysis, including the planning and integration of collection, processing, storage, shipping, and transfer logistics, as well as managing related reporting and billing.

You will also engage in data acquisition and management, working closely with data management leads to define how sample and testing data are captured, blinded, and transferred for clinical trials. Furthermore, you will provide vital guidance to clinical teams and sites regarding the proper collection, storage, and shipping of human samples, ensuring all activities comply with study protocols and applicable ICFs. This includes collaborating with the internal Human Sample Management team to ensure rigorous documentation, tracking, usage, and destruction of samples transferred to internal research groups.

Hiring Process

Qualified candidates will be evaluated based on their clinical research experience, knowledge of clinical trials and databases, and ability to work independently while contributing to group goals. The role requires a professional who can resolve problems spontaneously and possesses strong project management and organizational skills.

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.