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Title: Clinical Laboratory Study Manager

Duration: 9 month contract, potential to convert

Start Date: ASAP

Individual will work 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. 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.

A typical day might include the following:

• Participates in cross-functional study teams and sub-teams across clinical and research departments

• 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

• 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

This role may be for you if:

• You have excellent written and verbal communication skills

• You can handle and resolve problems spontaneously and possess strong project management and organizational skills

• You can work independently and proactively while still contributing to group initiatives and goals

• You have strong interpersonal skills and ability to work with many different groups/teams to achieve success

• Hands-on experience with database lock procedures in Phase I-IV clinical trials

+ To be considered for this role , you must have a B.S degree – Major/ Minor (Biology or equivalent) with 6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a professional with working knowledge of clinical trials and clinical databases.

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.