Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_onHelena Solid Waste Department, Centennial Trail, Helena, Lewis and Clark County, Montana, 59625, 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 primary mission is to ensure the delivery of high-quality samples and data. This support is essential for biomarker and non-biomarker evaluations, ultimately enabling the translation of scientific discoveries into effective medicines.
The role involves close collaboration with project managers from central and specialty labs, as well as Clinical Trial Management (CTM) and Contract Research Organizations (CROs). The incumbent will provide expertise to ensure samples are collected strictly according to protocol and will actively assist in resolving any sample-related issues or queries that arise during the trial lifecycle.
Day in the Life
You will act as a central hub for technical and operational sample-related matters. Your day may involve liaising with Informed Consent Form (ICF) specialists to review trial documents impacting sample testing, or assessing vendors to forecast operational costs and timelines. You will oversee the entire flow of sample analysis, including collection, processing, storage, shipping, and transfer, while ensuring accurate reporting and billing. Additionally, you will work closely with data management leads to determine how sample and testing data are captured, blinded, and transferred for clinical trials. A key part of your responsibility is providing guidance to clinical teams and sites regarding the compliance of sample collection, storage, and shipping, ensuring all activities align with study protocols and applicable ICFs.
Work location
Work model: Remote
Helena Solid Waste Department, Centennial Trail, Helena, Lewis and Clark County, Montana, 59625, United States
Helena, Montana
Key Responsibilities
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Skills, education and keywords
Skills: 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
Day-to-day, the Clinical Laboratory Study Manager - FSP at Parexel will provide guidance to clinical sites regarding sample collection, storage, and shipping compliance; assess vendors and forecast sample operational costs to align with budget plans; manage sample collection, processing, storage, shipping, and transfer operations for clinical trials; and coordinate with clinical study and data management teams to ensure quality sample and data delivery.
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: 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 Helena Solid Waste Department, Centennial Trail, Helena, Lewis and Clark County, Montana, 59625, United States. This is a remote role.