Thermo Fisher Scientific

Sr CM Analyst I

North Carolina, United States

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor’s degree or equivalent formal academic/vocational qualification, and a minimum of 5 years of experience in clinical monitoring, data management, biostatistics, or a related field supporting clinical trials. Strong organizational skills, adherence to regulatory guidelines, and global SOPs are required, along with excellent attention to detail and numerical skills, as well as proficiency with MS Office and interactive computer systems.

Responsibilities

As a Sr CM Analyst I, you will serve as the Centralized Monitoring functional lead, developing centralized monitoring plans and generating findings reports, managing review timelines, and supporting budget management. You will also communicate and work with the study team, ensure reviews are complete, lead Centralized Monitoring Review meetings, contribute to risk assessment through department tools, characterize and track evidence of issues, provide training and mentorship, and work under pressure while prioritizing multiple projects.

Skills

RBQM methodologies
Risk-based quality management
Statistical monitoring
Data assessment
Risk assessment
Monitoring plans
Report generation
Cross-functional collaboration
Training and mentorship

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.

Key Metrics

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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