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 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 tangible medical applications.

In this capacity, you will partner closely with project managers from central and specialty labs, offering expertise to Clinical Trial Management (CTM) and Contract Research Organizations (CROs). Your focus will be on ensuring samples are collected strictly according to protocol and assisting in the resolution of any sample-related issues or queries. Beyond technical execution, the role involves overseeing overall project management to align with the core business strategy.

Day-to-Day Impact

Your work will span the entire lifecycle of sample operations. You will support clinical study teams with technical and operational sample matters, liaising with internal stakeholders like ICF specialists to manage trial documents impacting samples and testing. You will establish and oversee the planning for sample collection, processing, storage, shipping, and transfer, while managing reporting and billing for study-related operations.

Collaboration with Precision Medicine Strategy Leads and scientists will involve assessing vendors, forecasting operational costs and timelines, and reviewing invoices to ensure budget alignment. You will also work directly with data management leads to define how sample and testing data are captured, blinded, and transferred for clinical trials.

A key component of the role is ensuring compliance and flow. You will provide guidance to clinical teams and sites regarding the collection, storage, and shipping of samples acquired during clinical trials. By working with scientists and clinical teams, you will ensure that sample collection and usage adhere to study protocols and applicable Informed Consent Forms (ICF). Additionally, you will coordinate with the internal Human Sample Management team to ensure all samples transferred to internal research groups are properly documented, tracked, utilized, and destroyed.

Hiring Process

Candidates selected for this role will be expected to complete the required training curriculum and maintain accurate timesheets and expense reports. The position requires the ability to work independently and proactively while contributing to group initiatives, necessitating strong interpersonal skills to collaborate effectively with diverse teams and platform lines.

Equal Opportunity Employer

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.