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

Day-to-Day Impact

You will provide comprehensive support to individual clinical study teams regarding all technical and operational sample-related matters. This involves liaising with internal stakeholders, such as collaborating with Informed Consent Form (ICF) specialists to address trial documents that impact sample collection and testing. You will establish, oversee, and plan the integration of all issues related to the collection, processing, storage, shipping, and transfer of samples and data, including reporting and billing for study operations.

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 closely with the data management lead to determine how sample and testing data are captured, blinded, and transferred for clinical trials. Additionally, you will guide clinical teams and sites on the proper collection, storage, and shipping of samples acquired during clinical trials or other human sample acquisition projects, ensuring compliance with study protocols and applicable ICFs.

Joining Parexel

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, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Application Process

Qualified candidates should possess 6 to 8 years of clinical research experience within academic, CRO, or pharmaceutical/biotech industries. Familiarity with clinical trials and clinical databases is essential, while laboratory sample management experience is a plus. A Bachelor's degree in a life science, nursing qualification, or other relevant experience is required. This role is remote, offering the flexibility to work from your location while contributing to a global team.