[Remote] Clinical Logistics Monitor - Global Clinical Supplies at Thermo Fisher Scientific

Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor's degree in a science-related field or Registered Nursing certification or equivalent relevant formal academic/vocational qualification
Previous experience of clinical trials and site monitoring, 2+ years that provide knowledge, skills, and abilities to perform the job
Experience working with clinical sites and familiarity with patient sample management, logistics processes (collection/shipments) associated with the IP
Cell & Gene Therapy experience preferred but not mandatory
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient

Responsibilities

Performs site management and other related activities on assigned Cell & Gene Therapies projects in accordance with approved protocols, ICH-GCP, GMP, GDP guidelines, applicable regulations, and organization's SOPs
Serves as a central point of contact focused on communication, site training, patient sample management, logistics (collection/shipments), analysis, and data management to provide seamless integration across patients, clinical sites/investigators, manufacturers, and logistics partners
Coordinates the process of clinical cellular material from harvest/production to infusion between the sponsor, manufacturer, logistics vendors, and investigator sites while ensuring chain of identity and chain of custody are intact to protect patient safety
Acts as the primary point of contact for all clinical sites and sponsor(s)
Oversees recruitment and slot allocation on the study (remote role)
Trains, supports, and manages study sites from site qualification through patient enrolment
Acts as lead support for Mock Run activities for cellular material harvest and patient sample/IP shipments
Provides clinical site personnel training, including refresher training on logistics activities
Oversees and coordinates the collection, processing, shipment to/from the manufacturing site, and return of patient’s cells for infusion, including quality review and distribution of all forms
Oversees material inventory (e.g., tumor harvest reagents, laboratory kits, co-therapy supplies) at site(s) and coordinates re-ordering as necessary
Tracks all samples and potential patients via organization systems, sponsor systems, or study-specific tools (e.g., vendor platform or cellular tracking flow sheet)
Liaises closely with all internal and external stakeholders, including Sponsor, investigator sites, Medical Monitor, organization's Central Labs (or outsourced vendor), organization's Project Delivery Lead, CMO, and shipping/logistics vendor
Assists with projects as assigned

Skills

ICH-GCP

GMP

GDP

site management

patient sample management

clinical logistics

chain of identity

chain of custody

Cell & Gene Therapies

data management

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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