Sr Centralized Monitoring Analyst I

Poland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

A Bachelor's degree or equivalent qualification is required, along with at least 5 years of experience in clinical monitoring, data management, biostatistics, or a related field supporting clinical trials. Strong organizational skills, meticulous attention to detail, and excellent numerical abilities are essential. Proven analytical and problem-solving skills, the ability to work both independently and collaboratively, and solid oral and written communication skills are necessary. Proficiency in MS Office and interactive computer systems is also required.

Responsibilities

The Senior Centralized Monitoring Analyst will serve as the functional lead for Centralized Monitoring, possessing knowledge of RBQM methodologies, tools, and processes. Responsibilities include developing centralized monitoring plans, generating findings reports, managing review timelines, and supporting budget management. The role involves acting as a functional representative to the study team, ensuring review completion, generating reports, and leading meetings to discuss issues and risks. Additionally, the analyst will contribute to risk assessments, track issues and potential risks, and provide training and mentorship to junior team members.

Skills

Centralized Monitoring

Risk-Based Quality Management (RBQM)

Statistical Monitoring

Data Analysis

Clinical Trials

Data Quality

Subject Safety

Monitoring Plans

Findings Reports

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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