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 Contract Research Organizations (CROs). Your expertise will be essential 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, fostering collaboration across internal stakeholders to optimize operational efficiency.

Day in the Life

Your work will span the entire lifecycle of sample management, from the initial planning stages to final data transfer. You will support 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 establishing and overseeing the collection, processing, storage, shipping, and transfer of samples and data, while also managing reporting and billing for study operations.

You will also engage in strategic planning by assessing vendors, forecasting operational costs and timelines, and reviewing invoices to ensure alignment with budget plans. Working closely with data management leads, you will determine the best methods for capturing, blinding, and transferring sample and testing data for clinical trials. Additionally, you will provide guidance to clinical teams and sites regarding the compliant collection, storage, and shipping of human samples, ensuring all activities adhere to study protocols and applicable ICFs. You will also coordinate with the internal Human Sample Management team to ensure rigorous documentation, tracking, usage, and destruction of samples transferred to internal research groups.

Hiring Process

Candidates selected for this role will be expected to complete the required training curriculum and maintain accurate timesheets and expense reports. Success in this position requires the ability to work independently and proactively while contributing effectively to group initiatives and goals.

Equal Opportunity Employer

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.