Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_onWest 16th Street, Indianapolis, Marion County, Indiana, 46202, United States
About the Role
The Clinical Laboratory Study Manager serves as a critical bridge between scientific strategy and operational execution within the Precision Medicine ecosystem. This role is designed to ensure the seamless delivery of high-quality samples and data, enabling the translation of complex science into tangible medical solutions. You will collaborate closely with the Precision Medicine Strategy Lead, clinical study teams, Data Management, and specialized groups like Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM).
In this position, you will oversee the entire lifecycle of clinical sample management—from collection and chain of custody to storage, shipping, and destruction. Your work ensures that samples are handled strictly in accordance with informed consent forms and study protocols. You will act as a key liaison between internal stakeholders, external vendors, and Clinical Research Organizations (CROs), resolving sample-related queries and ensuring that laboratory data generation meets rigorous quality standards.
Day in the Life
Your day involves a dynamic mix of strategic planning and hands-on operational support. You will participate in cross-functional study teams to develop informed consent forms and address regulatory escalations. A significant portion of your time will be dedicated to building and maintaining lab databases to meet specific 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 central and specialty labs. Beyond operations, you will engage in vendor management, including reviewing RFPs, assessing bids, and forecasting costs to align with budget plans. You will also provide essential guidance and training to clinical sites and vendors on proper sample collection, processing, and storage techniques, ensuring compliance with all applicable regulations and study protocols.
Work location
Work model: Remote
West 16th Street, Indianapolis, Marion County, Indiana, 46202, United States
Indianapolis, Indiana
Key Responsibilities
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; Bachelor's degree in 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
Day-to-day, the Clinical Laboratory Study Manager - FSP at Parexel will prepare rfps, review bids and sows for sample-related services and testing; ensure compliance with study protocols and informed consent forms for all human sample activities; 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 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 West 16th Street, Indianapolis, Marion County, Indiana, 46202, United States. This is a remote role.