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 alongside 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 effective medicines.

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, ensuring that sample collection adheres strictly to 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 build and manage lab databases to meet specific clinical 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, in coordination with central and specialty labs.

You will also drive operational support for sample analysis, overseeing the planning and integration of collection, processing, shipping, and transfer activities. This includes managing vendor relationships, forecasting operational costs, reviewing invoices, and preparing RFPs and SOWs. Additionally, you will provide guidance and training to vendors, collaborators, and clinical sites on proper sample handling procedures, ensuring compliance with protocols and ICFs. You will work closely with data management leads to define how sample and testing data are captured, blinded, and transferred, ensuring seamless data flow from vendors to internal systems.