Clinical Laboratory Study Manager - FSP

About the Role

The Clinical Laboratory Study Manager serves as a critical bridge between scientific strategy and operational execution within the clinical research ecosystem. Working in close partnership with the Precision Medicine Strategy Lead, this role ensures the seamless delivery of high-quality samples and data to support both biomarker and non-biomarker evaluations. The ultimate goal is to enable the translation of scientific discovery into tangible medical advancements.

In this position, you will oversee the entire lifecycle of clinical sample management, from collection and chain of custody to usage per informed consent, storage, and eventual destruction. You will act as the primary liaison between internal clinical study teams, data management groups, and external vendors, including central laboratories and specialty providers. Your expertise will be essential in resolving sample-related queries, ensuring protocol compliance, and supporting the generation of reliable laboratory data that drives clinical trial success.

Day in the Life

Your work will be highly collaborative, requiring you to navigate cross-functional study teams and sub-teams across clinical and research departments. A significant portion of your time will be dedicated to developing informed consent forms (ICFs) and addressing escalations from Institutional Review Boards (IRBs) or Ethics Committees (ECs). You will partner with project managers to build robust lab databases that address specific trial needs regarding kits, testing, and logistics.

You will monitor the acquisition and testing of diverse clinical samples, including human tissue, whole blood, plasma, and serum, while coordinating with the Samples, Kits, Data, Logistics (SKDL) team. Beyond operational oversight, you will engage in strategic planning by assessing vendors, forecasting costs, and reviewing invoices to align with budget plans. You will also prepare Requests for Proposals (RFPs), review bids, and oversee study start-up and closeout activities. Additionally, you will provide guidance and training to vendors, collaborators, and clinical sites on proper sample collection, processing, and shipping protocols.

Hiring Process

Qualified candidates will be considered for this remote opportunity. The selection process involves a review of your experience in clinical research lab study management and your ability to work independently while contributing to group initiatives.

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.