Thermo Fisher Scientific

Senior Clinical Research Associate

Romania

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

Requirements

Candidates must possess a Bachelor's degree in a life science field. Experience in clinical monitoring and site management, including audit readiness, is required. Familiarity with ICH-GCP guidelines and applicable regulations is essential. Experience with risk-based monitoring, root cause analysis, and critical thinking is also necessary.

Responsibilities

The Senior Clinical Research Associate will perform and coordinate clinical monitoring and site management, ensuring audit readiness. Responsibilities include conducting remote or on-site visits to assess compliance, managing documentation, and reviewing data for accuracy. They will assess investigational products, document observations, and report deficiencies to management. The role involves maintaining contact with investigative sites, participating in investigator meetings, initiating clinical trial sites, and performing trial close-outs. Additionally, they will ensure essential documents are complete, provide study status updates, and facilitate communication between sites, clients, and internal teams.

Skills

Clinical Monitoring
Site Management
Audit Readiness
Protocol Compliance
Regulatory Compliance
ICH-GCP
SOPs
Risk-Based Monitoring
Root Cause Analysis
Critical Thinking
Problem-Solving
Data Accuracy
SDV
CRF Review

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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