Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_on603, 3rd Street, West Albany, City of Albany, Albany County, New York, 12206, United States
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 involves active participation in cross-functional study teams, collaborating on the development of informed consent forms (ICF) and addressing regulatory escalations from IRBs or Ethics Committees. You will build and maintain lab databases to meet specific trial needs regarding kits, testing, and logistics, while 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 reporting. You will assess vendors, forecast operational costs, review invoices, and prepare Requests for Proposals (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 and ensure compliance with study protocols and applicable consent forms.
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.
Work location
Similar Job Opportunities
Skills, education and keywords
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.
Frequently asked questions about Clinical Laboratory Study Manager - FSP at Parexel
What does a Clinical Laboratory Study Manager - FSP at Parexel do?expand_more
In this Clinical Laboratory Study Manager - FSP at Parexel role, you will provide training and guidance to vendors and clinical sites on sample collection and storage procedures; monitor sample acquisition and testing at central labs while resolving sample-related queries; develop lab databases and prepare rfps, bids, and sows for sample testing and logistics; and manage central laboratory and specialty vendors to ensure quality sample and data delivery.
What are the requirements for this Clinical Laboratory Study Manager - FSP role?expand_more
To qualify for the Clinical Laboratory Study Manager - FSP at Parexel position, applicants should have: Bachelor's degree in life science, nursing, or relevant field; 6-8 years direct clinical research lab study management experience; and Working knowledge of clinical trials and clinical databases.
Where is the Clinical Laboratory Study Manager - FSP role at Parexel located?expand_more
Clinical Laboratory Study Manager - FSP at Parexel is based in 603, 3rd Street, West Albany, City of Albany, Albany County, New York, 12206, United States. This is a remote role.