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 tangible medical applications.

In this capacity, you will partner closely with project managers from central and specialty labs, lending expertise to Clinical Trial Management (CTM) and Contract Research Organizations (CROs). Your focus will be on ensuring samples are collected strictly according to protocol and assisting in the resolution of any sample-related issues or queries. Beyond technical execution, the role involves overarching project management aligned with the core business strategy.

Day-to-Day Impact

Your work will span the entire lifecycle of sample operations. You will support individual clinical study teams by acting as the liaison for all technical and operational sample-related matters. This includes collaborating with Informed Consent Form (ICF) specialists to ensure trial documents accurately reflect sample and testing requirements.

You will establish, oversee, and integrate the planning for sample collection, processing, storage, shipping, and transfer, while managing reporting and billing for study operations. By assessing vendors, forecasting operational costs, and reviewing invoices, you will ensure alignment with budget plans while liaising with Precision Medicine Strategy Leads and scientists.

On the data front, you will work directly with data management leads to define how sample and testing data are captured, blinded, and transferred for clinical trials. You will also provide guidance to clinical teams and sites regarding the collection, storage, and shipping of samples, ensuring compliance 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 properly documented, tracked, utilized, and destroyed.

Hiring Process

Qualified candidates will be evaluated based on their ability to work independently and proactively while contributing to group initiatives. The role requires strong problem-solving skills and the ability to collaborate effectively with diverse teams.

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.