Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_onFranklin Street, Downtown, Providence, Providence County, Rhode Island, 02902, 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, tracking, and eventual destruction. You will act as a key liaison between internal stakeholders and external vendors, ensuring that sample collection adheres strictly to study protocols. Your expertise will be instrumental in resolving sample-related queries and supporting Clinical Trial Management (CTM) and CRO partners 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/ECs. You will partner with project managers 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, often in coordination with the SKDL team.
You will also manage the operational aspects of sample analysis, including the planning and integration of collection, processing, storage, shipping, and transfer protocols. This includes overseeing budget alignment by assessing vendors, forecasting costs, and reviewing invoices. Additionally, you will prepare Requests for Proposals (RFPs), review bids and Statements of Work (SOWs), and provide guidance and training to vendors, collaborators, and clinical sites on proper sample handling procedures.
Hiring Process
Qualified candidates will be considered for this remote position. 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
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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
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; 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 Franklin Street, Downtown, Providence, Providence County, Rhode Island, 02902, United States. This is a remote role.