Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_on6317, West Markham Street, Little Rock, Big Rock Township, Pulaski County, Arkansas, 72205, 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, 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, tracking, 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 (ICFs) and addressing regulatory escalations. 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, planning the collection, processing, storage, shipping, and transfer of samples and data. 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, ensuring compliance with study protocols and applicable ICFs.
Hiring Process
Qualified candidates will be invited to participate in a series of interviews designed to assess technical expertise, project management capabilities, and cultural fit. The process typically includes a review of relevant experience in clinical research lab study management within the CRO or pharmaceutical/biotech industry, followed by discussions with the hiring team and potential cross-functional partners.
Equal Opportunity Employer
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
Work model: Remote
6317, West Markham Street, Little Rock, Big Rock Township, Pulaski County, Arkansas, 72205, United States
Little Rock, Arkansas
Key Responsibilities
- check_circleEstablish oversight for sample collection, processing, storage, shipping, and data transfer operations
- check_circlePrepare RFPs, review bids and SOWs for sample-related items and testing services
- check_circleProvide guidance and training to vendors and clinical sites on sample collection and storage protocols
- check_circleEnsure sample collection and usage compliance with study protocols and applicable informed consent forms
- check_circleMonitor acquisition and testing of clinical trial samples including human tissue and blood products
- check_circleManage central laboratory and specialty vendor relationships for sample testing and logistics
- check_circleOversee clinical sample collection, usage, tracking, and destruction per informed consent forms
- check_circleCoordinate with project managers to build lab databases addressing kit, testing, and logistics needs
Requirements
- verifiedBachelor's degree in life science, nursing, or relevant field
- verified6-8 years direct clinical research lab study management experience
- verifiedWorking knowledge of clinical trials and clinical databases
Nice to Have
Laboratory sample management experience
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 establish oversight for sample collection, processing, storage, shipping, and data transfer operations; prepare rfps, review bids and sows for sample-related items and testing services; provide guidance and training to vendors and clinical sites on sample collection and storage protocols; and ensure sample collection and usage compliance with study protocols and applicable informed consent forms.
What are the requirements for this Clinical Laboratory Study Manager - FSP role?expand_more
Parexel is looking for candidates who meet the following requirements: 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 6317, West Markham Street, Little Rock, Big Rock Township, Pulaski County, Arkansas, 72205, United States. This is a remote role.
Is this Clinical Laboratory Study Manager - FSP job remote, hybrid, or on-site?expand_more
Parexel has listed this Clinical Laboratory Study Manager - FSP role as remote.
How much experience is required for this Clinical Laboratory Study Manager - FSP role?expand_more
Clinical Laboratory Study Manager - FSP at Parexel typically requires 6–8 years of relevant experience at the senior level.
What skills do you need for the Clinical Laboratory Study Manager - FSP role at Parexel?expand_more
Key skills for Clinical Laboratory Study Manager - FSP at Parexel include Clinical Trials; Clinical Databases; Laboratory Sample Management; and Microsoft Applications.
What education is required for Clinical Laboratory Study Manager - FSP at Parexel?expand_more
Educational requirements for this role: Bachelor's degree in a life science required; and Nursing qualification (Bachelor's level) required.
What category does the Clinical Laboratory Study Manager - FSP role belong to?expand_more
Clinical Laboratory Study Manager - FSP at Parexel is part of the scientific & qa job category on Recrutus.