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.

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

You will support individual clinical study teams by handling all technical and operational sample-related matters. This involves liaising with internal stakeholders, including 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 component of the role is data acquisition and management. You will collaborate with data management leads to determine 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 acquired during clinical trials or other human sample acquisition projects. Ensuring compliance with study protocols and applicable ICFs is essential, as is working with the internal Human Sample Management team to document, track, use, and properly destroy all samples transferred to internal research groups.

Hiring Process & Application

Qualified candidates will be evaluated on their ability to work independently while contributing to group initiatives, their problem-solving skills, and their capacity to collaborate across diverse teams. The ideal candidate possesses excellent written and verbal communication skills and is proficient with Microsoft applications.

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.