Sr CRA (Level I) - with French and/or Italian at Thermo Fisher Scientific

Switzerland

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

Requirements

Candidates should have at least two years of onsite monitoring experience, with a focus on oncology. Experience with French and/or Italian language skills is required for this role. The position necessitates overnight travel, either regionally or nationally, based on business requirements.

Responsibilities

The Sr CRA will perform and coordinate all aspects of clinical monitoring and site management, including remote and on-site visits to assess protocol and regulatory compliance. Responsibilities include managing various sponsor procedures, acting as a site processes specialist to ensure adherence to protocols and regulations, and maintaining audit readiness. The role involves developing site relationships, applying risk-based monitoring with root cause analysis, ensuring data accuracy through reviews, assessing investigational products, documenting observations, escalating deficiencies, and resolving issues. The Sr CRA will also provide trial status updates, maintain study systems, participate in investigator meetings, and identify potential investigators.

Skills

Clinical Monitoring
Site Management
Protocol Compliance
Regulatory Compliance
ICH-GCP
Oncology
French
Italian

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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