Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_on110, South Grand Avenue West, Hawthorne Place, Springfield, Sangamon County, Illinois, 62704, 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 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, tracking, and eventual destruction. You will act as a key liaison between internal stakeholders and external vendors, ensuring that sample collection strictly adheres to study protocols. Your expertise will be vital 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 closely with project managers and set-up teams to build robust lab databases that address specific clinical trial needs for kits, testing, and logistics. You will monitor the acquisition and testing of diverse sample types, including human tissue, whole blood, plasma, and serum, while coordinating with SKDL to support operational requirements.
A significant portion of your time will be dedicated to establishing and overseeing the planning for sample collection, processing, storage, shipping, and transfer. You will manage vendor relationships, including the preparation of RFPs, assessment of bids and Statements of Work (SOWs), and the review of invoices to ensure alignment with budget plans. Additionally, you will provide guidance and training to vendors, collaborators, and clinical sites on proper sample handling procedures.
On the data front, you will partner with data management leads to define how sample and testing data are captured, blinded, and transferred. This includes developing data transfer specifications and ensuring compliance with study protocols and informed consent forms. You will also support audit activities and oversee study start-up and closeout phases for central and specialty labs.
Hiring Process
Qualified candidates will be considered for this remote opportunity. The selection process involves reviewing applications to identify individuals with the necessary background in clinical research lab study management within the CRO or pharmaceutical/biotech industry.
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.
Similar Job Opportunities
Skills, education and keywords
Skills: Clinical Trials, Clinical Databases, Microsoft Applications, Laboratory Sample Management.
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
Day-to-day, the Clinical Laboratory Study Manager - FSP at Parexel 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 110, South Grand Avenue West, Hawthorne Place, Springfield, Sangamon County, Illinois, 62704, United States. This is a remote role.