Clinical Laboratory Study Manager - FSP

Parexel•Southport, NC

18h

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine. Will work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy. Operations Management Study Team Support Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing Operational Support of Sample Analysis (including exploratory analysis) Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations Liaises with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, timelines and reviewing invoices to ensure alignment with budget plans Data Acquisition and Management Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials Human Sample Management Flow and Compliance Provides guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed Compliance with Parexel Standards Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery

Requirements

Excellent written and verbal communication skills
Resolve problems spontaneously and possess strong project management and organizational skills
Work independently and proactively while still contributing to group initiatives and goals
Good interpersonal skills and ability to work with many different groups/teams
Microsoft applications
6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry
working knowledge of clinical trials and clinical databases
Bachelor’s degree in a life science, nursing qualification or other relevant experience required

Nice To Haves

Laboratory sample management experience is a plus.

Responsibilities

Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing
Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations
Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials
Provides guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects
Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF
Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery