Clinical Laboratory Study Manager - FSP

Parexel•Southport, NC

About The Position

The Clinical Laboratory Study Manager works with the Precision Medicine Strategy Lead, 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. Responsibilities include oversight of clinical sample collection, usage per informed consent form, sample tracking (chain of custody), management of central laboratory and specialty vendors, and sample destruction. The individual will work closely with internal and external groups/vendors to manage and support the generation of quality laboratory data. They will collaborate 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.

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
Experience with Microsoft applications
6 - 8 years direct clinical research lab study management experience within the 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 field required.

Nice To Haves

Laboratory sample management experience is a plus.

Responsibilities

Participates in cross-functional study teams and sub-teams across clinical and research departments.
Works with clinical study team on the development of the informed consent forms (ICF), including escalations from IRBs/ECs.
Works with project manager and set-up manager of central/specialty lab and clinical study team to build lab database to address clinical trial need of kits, testing and logistics.
Monitors acquisition of clinical trial samples (including human tissue, whole blood, plasma, serum, etc) and testing at central/specialty lab with support from SKDL.
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 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.
Liaises with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, timelines and reviewing invoices to ensure we are aligned with budget plans.
Provides input on sample-related section in clinical trial-related (e.g. protocols and ICF) and other supporting documents.
Prepares RFPs, reviews and assess bids and SOWs for items related to samples and testing.
Participates in oversight activities with vendors and other collaborators, and supports audits as required.
Oversees study start up, closeout and overall life-cycle activities for assigned studies at central lab/specialty labs to support all samples and testing.
Provides guidance and trainings to vendors, collaborators and clinical sites on sample collection, processing, shipping, and storage.
Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials.
Enables transfer of sample/testing data from vendor through development and review of an appropriate data transfer specification and related documents in collaboration with SKDL.
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.