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 resolving any sample-related queries that arise. Beyond technical oversight, you will drive overall project management aligned with the core business strategy, managing the full lifecycle of sample operations from collection and processing to storage, shipping, and transfer.

Day in the Life

Your work involves a dynamic mix of operational support, data acquisition, and compliance management. You will collaborate 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 logistics of sample analysis, including exploratory analysis, while managing reporting and billing for study operations.

You will partner with Precision Medicine Strategy Leads and scientists to assess vendors, forecast operational costs and timelines, and review invoices to maintain budget alignment. Additionally, you will work closely with data management leads to define how sample and testing data are captured, blinded, and transferred for clinical trials. On the compliance front, you will provide guidance to clinical teams and sites regarding the 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, and proper disposal of samples transferred to research groups.

Hiring Process

Candidates are expected to demonstrate strong project management and organizational skills, with the ability to resolve problems spontaneously and work independently while contributing to group goals. The role requires excellent written and verbal communication skills and the ability to build effective relationships across diverse teams and platforms.

Equal Opportunity

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.