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, storage, and eventual destruction. You will act as a key liaison between internal stakeholders and external vendors, including central and specialty laboratories, to ensure samples are collected strictly according to protocol. Your expertise will be vital in resolving sample-related queries, managing vendor relationships, and supporting Clinical Trial Management (CTM) and CROs to maintain data integrity throughout the trial.

Day in the Life

Your work will span cross-functional collaboration and strategic project management. You will participate in study teams to develop informed consent forms (ICFs) and address regulatory escalations from IRBs/ECs. A significant portion of your time will be dedicated to building lab databases that address specific clinical trial needs regarding kits, testing, and logistics.

You will monitor the acquisition and testing of various sample types, including human tissue, whole blood, plasma, and serum, while ensuring compliance with study protocols and applicable consent forms. Beyond operations, you will engage in financial oversight by assessing vendors, forecasting operational costs, and reviewing invoices to align with budget plans. You will also prepare Requests for Proposals (RFPs), review bids and Statements of Work (SOWs), and provide guidance and training to vendors and clinical sites on proper sample collection, processing, and shipping procedures.

Hiring Process

Qualified candidates will be invited to participate in a series of interviews designed to assess both technical expertise and cultural fit. The process typically includes a screening call with the recruiting team, followed by in-depth discussions with the hiring manager and cross-functional stakeholders to evaluate your experience in clinical research lab study management and your ability to navigate complex operational challenges.

Equal Opportunity Employer

Parexel is an equal opportunity employer. We are committed to building a diverse and inclusive workforce and will consider qualified applicants for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.