Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_onWest 16th Street, Indianapolis, Marion County, Indiana, 46202, United States
About the Role
This position serves as a critical bridge between scientific strategy and clinical execution. Working alongside the Precision Medicine Strategy Lead, clinical study teams, and specialized groups such as Data Management, Samples, Kits, Data, Logistics (SKDL), and Clinical Laboratory Project Management (CLPM), the 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 practical medicine.
You will act as a subject matter expert for project managers and CROs, ensuring sample collection strictly adheres to study protocols. Beyond technical oversight, you will manage operational aspects including the establishment and integration of sample collection, processing, storage, shipping, and transfer workflows. This includes coordinating with data management leads to define how sample and testing data are captured, blinded, and transferred for clinical trials, as well as managing vendor assessments, cost forecasting, and budget alignment.
A key component of this role is ensuring compliance with study protocols and Informed Consent Forms (ICF) while providing guidance to clinical sites on human sample management. You will work closely with internal teams to ensure all samples transferred to research groups are accurately documented, tracked, utilized, and disposed of according to standards.
Hiring Process
Candidates selected for this role will be expected to complete the required training curriculum and maintain accurate timesheets and expense reports. Success in this position requires the ability to work independently while proactively contributing to group initiatives and maintaining effective relationships across various platform lines and business units.
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
West 16th Street, Indianapolis, Marion County, Indiana, 46202, United States
Indianapolis, Indiana
Key Responsibilities
- check_circleProvide guidance to clinical sites regarding sample collection, storage, and shipping compliance with ICF and study requirements
- check_circleAssess vendors, forecast operational costs, and review invoices to ensure alignment with budget plans
- check_circleCollaborate with clinical study and data management teams to ensure quality sample and data delivery for biomarker evaluation
- check_circleOversee project management activities to support the core business strategy and clinical trial management
- check_circleManage sample collection, processing, storage, shipping, and transfer operations in alignment with study protocols
- check_circleCoordinate with data management leads to determine how sample and testing data will be captured, blinded, and transferred
- check_circleEnsure all human samples transferred to internal research groups are properly documented, tracked, and disposed of
Requirements
- verified6-8 years clinical research experience
- verifiedBachelor's degree in life science, nursing qualification, or other relevant experience
- verifiedWorking knowledge of clinical trials and clinical databases
- verifiedMicrosoft applications
Nice to Have
Laboratory sample management experience
Similar Job Opportunities
Skills, education and keywords
Skills: Clinical Trial Management, Clinical Research, Clinical Trials, Clinical Databases, Laboratory Sample Management, Microsoft Applications.
Education: Bachelor's degree in a life science 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 provide guidance to clinical sites regarding sample collection, storage, and shipping compliance with icf and study requirements; assess vendors, forecast operational costs, and review invoices to ensure alignment with budget plans; collaborate with clinical study and data management teams to ensure quality sample and data delivery for biomarker evaluation; and oversee project management activities to support the core business strategy and clinical trial 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: 6-8 years clinical research experience; Bachelor's degree in life science, nursing qualification, or other relevant experience; Working knowledge of clinical trials and clinical databases; and 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 West 16th Street, Indianapolis, Marion County, Indiana, 46202, 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 Clinical Trial Management; Clinical Research; Clinical Trials; Clinical Databases; Laboratory Sample Management; and Microsoft Applications.
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.
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.