Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_on1100, H Street Northwest, Downtown, Ward 2, Washington, District of Columbia, 20006, 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 like Data Management (DM) and Samples, Kits, Data, Logistics (SKDL), 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 manage the entire lifecycle of clinical samples, from collection and chain of custody to storage, shipping, and destruction. You will act as a key liaison between internal stakeholders, external vendors, and Clinical Research Organizations (CROs) to ensure all sample-related activities align with study protocols and informed consent forms. Your expertise will be essential in resolving complex sample-related queries and guiding project managers to maintain the integrity of laboratory data generation.
Day in the Life
Your work will be dynamic, balancing cross-functional collaboration with detailed operational oversight. You will participate in study teams to help develop informed consent forms and address regulatory escalations. A significant portion of your time will be dedicated to building lab databases that meet specific clinical trial needs, monitoring the acquisition of human tissue and blood products, and overseeing the setup of central and specialty labs.
You will also manage vendor relationships, assessing bids, reviewing statements of work, and forecasting operational costs to ensure alignment with budget plans. Additionally, you will provide guidance and training to clinical sites on proper sample collection and handling, while collaborating with data management leads to define how sample and testing data are captured, blinded, and transferred.
Hiring Process
Qualified candidates will be invited to participate in a structured interview process designed to assess both technical expertise and cultural fit. This typically includes an initial screening to discuss background and experience, followed by deeper technical discussions regarding clinical trial management and sample logistics. Final stages may involve scenario-based problem-solving and meetings with key team members to ensure alignment with the group's goals.
Equal Opportunity Employer
Parexel is an equal opportunity employer. We are committed to building a diverse and inclusive workforce and will consider qualified applicants for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Work location
Work model: Remote
1100, H Street Northwest, Downtown, Ward 2, Washington, District of Columbia, 20006, United States
Washington, District of Columbia
Key Responsibilities
- check_circleMonitor acquisition and testing of clinical samples including human tissue, blood, plasma, and serum
- check_circleProvide guidance and training to vendors, collaborators, and clinical sites on sample management
- check_circleEnsure compliance with study protocols and informed consent forms for all sample collection and usage
- check_circlePrepare RFPs, review bids and SOWs, and assess vendor invoices to align with budget plans
- check_circleEstablish and oversee sample collection, processing, storage, shipping, and data transfer workflows
- check_circleManage central laboratory and specialty vendor relationships for sample testing and logistics
- check_circleSupport development of informed consent forms and clinical trial documents regarding sample handling
- check_circleOversee clinical sample collection, usage, tracking, and destruction per informed consent and protocol
Requirements
- verifiedBachelor's degree in life science, nursing, or relevant field
- verified6-8 years direct clinical research lab study management experience
- verifiedWorking knowledge of clinical trials and clinical databases
Nice to Have
Laboratory sample management experience
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 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 monitor acquisition and testing of clinical samples including human tissue, blood, plasma, and serum; provide guidance and training to vendors, collaborators, and clinical sites on sample management; ensure compliance with study protocols and informed consent forms for all sample collection and usage; and prepare rfps, review bids and sows, and assess vendor invoices to align with budget plans.
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 1100, H Street Northwest, Downtown, Ward 2, Washington, District of Columbia, 20006, 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 Trials; Clinical Databases; Microsoft Applications; and Laboratory Sample Management.
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; and Nursing qualification 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.