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 including 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.

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 overseeing overall project management to align with the core business strategy.

Day-to-Day Impact

You will act as a liaison for internal stakeholders, supporting individual clinical study teams with technical and operational sample-related matters. This includes collaborating with Informed Consent Form (ICF) specialists to manage trial documents that impact sample testing. You will establish, oversee, and integrate the full lifecycle of sample operations—covering collection, processing, storage, shipping, and transfer—while managing reporting and billing for study-related activities.

A key part of your workflow involves assessing vendors, forecasting operational costs and timelines, and reviewing invoices to ensure alignment with budget plans. You will work directly 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 collection, storage, and shipping of samples, ensuring all activities comply with study protocols and applicable ICFs. You will also coordinate with the internal Human Sample Management team to ensure all samples transferred to research groups are accurately documented, tracked, utilized, and destroyed.

Hiring Process

Candidates selected for this role will be expected to complete the required training curriculum, maintain accurate timesheets and expense reports, and keep their professional profiles up to date. Success in this position requires the ability to maintain effective relationships across various platform lines, Business Units, and Research Units to facilitate portfolio delivery.

Our Culture & Commitment to Diversity

Parexel is an equal opportunity employer. We are committed to fostering a diverse and inclusive environment where qualified applicants receive consideration for employment without regard to legally protected status. In the US, this includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. We value the unique perspectives and experiences that every team member brings to our mission of advancing science and medicine.