Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_on154, South Maryland Street, Capitol Heights, Montgomery, Montgomery County, Alabama, 36107, United States
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 like Data Management (DM) and Samples, Kits, Data, Logistics (SKDL), 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, 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.
Day in the Life
Your work will be highly collaborative, requiring you to participate in cross-functional study teams and sub-teams across clinical and research departments. You will collaborate with project managers and set-up teams to build lab databases that address 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.
You will also drive operational support for sample analysis, overseeing the planning and integration of collection, processing, shipping, and data transfer. This involves liaising with ICF specialists to ensure trial documents accurately reflect sample requirements and preparing Requests for Proposals (RFPs) to assess vendor bids. 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 informed consent forms.
Hiring Process
Qualified candidates will be considered for this remote opportunity. The selection process focuses on identifying individuals with strong project management skills and the ability to work independently while contributing to group initiatives.
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
154, South Maryland Street, Capitol Heights, Montgomery, Montgomery County, Alabama, 36107, United States
Montgomery, Alabama
Key Responsibilities
- check_circleProvide guidance and training to vendors and clinical sites on sample collection and storage procedures
- check_circleMonitor sample acquisition and testing at central labs while resolving sample-related queries
- check_circleDevelop lab databases and prepare RFPs, bids, and SOWs for sample testing and logistics
- check_circleManage central laboratory and specialty vendors to ensure quality sample and data delivery
- check_circleOversee clinical sample collection, usage, tracking, and destruction in compliance with informed consent forms
- check_circleCollaborate with data management leads to define sample data capture, blinding, and transfer protocols
- check_circleCoordinate study start-up, closeout, and lifecycle activities for assigned clinical trials
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 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
A Clinical Laboratory Study Manager - FSP at Parexel is responsible for the following: Provide guidance and training 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 154, South Maryland Street, Capitol Heights, Montgomery, Montgomery County, Alabama, 36107, 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 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.