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 effective medicine.

You will act as a subject matter expert for clinical trial management, collaborating closely with project managers from central and specialty labs, as well as Contract Research Organizations (CROs). Your expertise will be vital in ensuring samples are collected strictly according to protocol and in assisting with the resolution of any sample-related issues or queries. Beyond technical oversight, you will drive overall project management aligned with the core business strategy, ensuring operational efficiency and strategic alignment.

Day in the Life

Your work involves a dynamic mix of operational support, data management, and compliance. You will liaise with internal stakeholders, including Informed Consent Form (ICF) specialists, to address technical and operational sample-related matters. A significant portion of your time will be dedicated to the establishment and oversight of sample analysis workflows, covering the entire lifecycle from collection and processing to storage, shipping, and transfer.

You will also engage in strategic planning by assessing vendors, forecasting operational costs and timelines, and reviewing invoices to ensure budget alignment. Collaborating with data management leads, you will define how sample and testing data are captured, blinded, and transferred for clinical trials. Furthermore, you will provide essential guidance to clinical teams and sites regarding the collection, storage, and shipping of human samples, ensuring all activities comply with study protocols and applicable informed consent forms.

Hiring Process

Qualified candidates will be invited to participate in a structured interview process designed to assess both technical expertise and cultural fit. This typically includes an initial screening to discuss background and experience, followed by a deeper technical discussion regarding clinical trial management and sample logistics. Final stages may involve scenario-based problem-solving and meetings with key team members to ensure alignment with the group's goals.

Equal Opportunity Employer

Parexel is an equal opportunity employer. We are committed to building a diverse and inclusive workforce. 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.