Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_onBeacon Street Mall, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, 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 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, tracking, and final destruction. You will act as a key liaison between internal stakeholders and external vendors, managing central and specialty laboratories to ensure samples are collected strictly according to protocol. Your expertise will be vital in resolving sample-related queries and supporting Clinical Trial Management (CTM) and CRO partners.
Beyond operational oversight, you will drive project management aligned with core business strategies. This includes establishing and integrating processes for sample collection, processing, storage, shipping, and data reporting. You will collaborate with scientists to assess vendors, forecast costs, and review invoices to maintain budget alignment. Additionally, you will prepare Requests for Proposals (RFPs), review bids and Statements of Work (SOWs), and provide guidance and training to vendors and clinical sites on best practices for sample handling.
Hiring Process
Qualified candidates will be considered for this remote position. The selection process involves reviewing applications for alignment with the required 6-8 years of direct clinical research lab study management experience within the CRO or pharmaceutical/biotech industry.
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
Work model: Remote
Beacon Street Mall, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, United States
Boston, Massachusetts
Key Responsibilities
- check_circleDevelop informed consent forms and provide input on clinical trial protocols
- check_circleMonitor sample testing at central labs and resolve related operational issues
- check_circlePrepare RFPs, review bids, and assess SOWs for sample and testing services
- check_circleOversee clinical sample collection, tracking, and chain of custody management
- check_circleManage central laboratory and specialty vendor relationships and performance
- check_circleProvide training to vendors and clinical sites on sample collection and handling procedures
- check_circleCoordinate sample acquisition, processing, storage, shipping, and destruction
- check_circleCollaborate with data management teams to define data capture and transfer specifications
Requirements
- verifiedBachelor's degree in a life science, nursing qualification or other relevant field
- verified6-8 years direct clinical research lab study management experience within CRO or pharmaceutical/biotech industry
- verifiedWorking knowledge of clinical trials and clinical databases
- verifiedExperience with Microsoft applications
Nice to Have
Laboratory sample management experience
Similar Job Opportunities
Skills, education and keywords
Skills: Microsoft Applications, Clinical Trials, Clinical Databases, Laboratory Sample Management.
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: Develop informed consent forms and provide input on clinical trial protocols; Monitor sample testing at central labs and resolve related operational issues; Prepare RFPs, review bids, and assess SOWs for sample and testing services; and Oversee clinical sample collection, tracking, and chain of custody management.
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 a life science, nursing qualification or other relevant field; 6-8 years direct clinical research lab study management experience within CRO or pharmaceutical/biotech industry; Working knowledge of clinical trials and clinical databases; and Experience with Microsoft applications.
Where is the Clinical Laboratory Study Manager - FSP role at Parexel located?expand_more
Clinical Laboratory Study Manager - FSP at Parexel is based in Beacon Street Mall, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, 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 Microsoft Applications; Clinical Trials; Clinical Databases; and Laboratory Sample Management.
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.