Clinical Laboratory Study Manager - FSP

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 assist in resolving any sample-related issues or queries that arise during the trial lifecycle. Beyond operational execution, the role contributes to overall project management aligned with the core business strategy.

Day-to-Day Impact

In this capacity, you will support individual clinical study teams with all technical and operational sample-related matters. This includes liaising with internal stakeholders, such as Informed Consent Form (ICF) specialists, to manage trial documents that impact sample collection and testing. You will oversee the planning and integration of sample analysis, including exploratory analysis, while managing the full lifecycle of sample handling: collection, processing, storage, shipping, and transfer.

A key component of the role involves data acquisition and management. You will work closely with data management leads to determine how sample and testing data are captured, blinded, and transferred for clinical trials. Additionally, you will provide guidance to clinical teams and sites regarding the collection, storage, and shipping of samples acquired during clinical trials or other human sample acquisition projects. Ensuring compliance with study protocols and applicable ICFs is paramount, as is maintaining rigorous documentation for all samples transferred to internal research groups.

Hiring Process & Application

Qualified candidates will be evaluated based on their clinical research experience and ability to work independently while contributing to group initiatives. The selection process focuses on identifying professionals with strong project management and organizational skills who can resolve problems spontaneously and communicate effectively across diverse teams.

Our Culture & Commitment to Diversity

Parexel is an equal opportunity employer. We are committed to fostering a diverse and inclusive environment where qualified applicants receive consideration for employment without regard to legally protected status. In the US, this includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. We strive to maintain effective relationships across all platform lines, Business Units, and Research Units to facilitate effective portfolio delivery.