Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_on690, South 13th Street, Downtown, Boise, Ada County, Idaho, 83702, United States
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, SKDL (Samples, Kits, Data, Logistics), and 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, storage, and destruction. You will act as a key liaison between internal stakeholders, external vendors, and Clinical Research Organizations (CROs) to ensure samples are collected strictly according to protocol. Your expertise will be vital in resolving sample-related queries, managing central and specialty laboratory vendors, and aligning project management with core business strategies.
Your work involves active participation in cross-functional study teams, collaborating on the development of informed consent forms (ICFs) and addressing regulatory escalations. You will build and maintain lab databases to meet specific clinical trial needs, monitoring the acquisition and testing of various sample types, including human tissue, whole blood, plasma, and serum.
A significant portion of your time will be dedicated to operational oversight, including the planning and integration of sample collection, processing, shipping, and data transfer. You will assess vendors, forecast operational costs, and review invoices to ensure budget alignment. Additionally, you will prepare Requests for Proposals (RFPs), review bids, and provide guidance and training to vendors and clinical sites on proper sample handling procedures. You will also work closely with data management leads to define how sample and testing data are captured, blinded, and transferred, ensuring full compliance with study protocols and applicable consent forms.
Work model: Remote
690, South 13th Street, Downtown, Boise, Ada County, Idaho, 83702, United States
Boise, Idaho
Laboratory sample management experience
Skills: Clinical Trials, Clinical Databases, Laboratory Sample Management, Microsoft Applications.
Education: Bachelor's degree in a life science required; Nursing qualification (Bachelor's level) required.