Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_onEast 14th Avenue, Capitol Hill, Denver, Colorado, 80264, 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, managing central laboratories and specialty labs 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 CROs to maintain data integrity throughout the study.
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. 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 support, establishing oversight for sample collection, processing, storage, shipping, and data reporting. You will assess vendors, forecast operational costs, and review invoices to ensure alignment with budget plans. 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.
You will also work closely with data management leads to define how sample and testing data are captured, blinded, and transferred, ensuring seamless integration between vendor outputs and internal systems. Compliance is a core focus, requiring you to ensure all sample collection and usage aligns with study protocols and applicable consent forms, while maintaining rigorous documentation for samples transferred to internal research groups.
Hiring Process
Qualified candidates will be considered for this remote position. The selection process involves reviewing applications to identify individuals with the necessary blend of clinical research lab study management experience and project management skills.
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.
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
In this Clinical Laboratory Study Manager - FSP at Parexel role, you will prepare rfps, review bids and sows for sample-related services and testing; collaborate with study teams to develop informed consent forms and clinical trial protocols; establish and oversee sample collection, processing, storage, shipping, and data transfer workflows; and manage central laboratory and specialty vendor relationships for sample testing and logistics.
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 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 East 14th Avenue, Capitol Hill, Denver, Colorado, 80264, United States. This is a remote role.