Clinical Laboratory Study Manager - FSP

About the Role

The Clinical Laboratory Study Manager serves as a critical bridge between scientific strategy and operational execution. Working closely with the Precision Medicine Strategy Lead, clinical study teams, and specialized groups such as Data Management (DM), Samples, Kits, Data, Logistics (SKDL), and Clinical Laboratory Project Management (CLPM), this 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 treatments.

In this position, you will oversee the entire lifecycle of clinical sample management, from collection and chain of custody to usage per informed consent forms, tracking, and eventual destruction. You will act as a key liaison between internal stakeholders and external vendors, ensuring that sample collection aligns strictly with study protocols. Your expertise will be vital in resolving sample-related queries and supporting Clinical Trial Management (CTM) and CRO partners to maintain data integrity throughout the trial.

Day in the Life

Your work involves active participation in cross-functional study teams, collaborating on the development of informed consent forms (ICF) and addressing regulatory escalations from IRBs/ECs. You will partner with project managers to build lab databases that address specific trial needs regarding kits, testing, and logistics. A significant portion of your time will be dedicated to monitoring the acquisition and testing of clinical samples, including human tissue, whole blood, plasma, and serum, often in coordination with the SKDL team.

You will also manage the operational flow of sample analysis, overseeing collection, processing, storage, shipping, and transfer. This includes forecasting operational costs, reviewing invoices, and preparing RFPs to ensure alignment with budget plans. Additionally, you will provide guidance and training to vendors, collaborators, and clinical sites on proper sample handling procedures, while working with data management leads to define how sample and testing data are captured, blinded, and transferred.

Hiring Process

Qualified candidates will be considered for this remote opportunity. The selection process focuses on identifying individuals with strong project management capabilities and deep experience in clinical research lab study management within the CRO or pharmaceutical/biotech sectors.

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.