Thermo Fisher Scientific

Senior CRA I (with Italian and French Language)

Switzerland

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

Requirements

Candidates should possess two or more years of onsite monitoring experience and experience monitoring oncology, along with a strong understanding of ICH-GCP guidelines and applicable regulations. The role requires overnight travel either regionally or nationally, dependent on business needs, and the ability to conduct remote or on-site visits to assess protocol and regulatory compliance.

Responsibilities

The Senior CRA I will perform and coordinate all aspects of the clinical monitoring and site management process, conducting remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. They will also manage procedures and guidelines from different sponsors and/or monitoring environments, act as a site processes specialist ensuring trial compliance, develop collaborative relationships with investigational sites, conduct monitoring tasks in accordance with the approved monitoring plan, and participate in investigator meetings as necessary. Additionally, the role involves monitoring investigator sites with a risk-based approach, applying RCA and problem-solving skills, ensuring data accuracy, documenting observations, escalating issues, and providing trial status tracking reports to the Clinical Team Manager.

Skills

Clinical Monitoring
Oncology
Regulatory Compliance
Site Management
Documentation Management
Remote and On-site Visits
Protocol Adherence
Trial Procedures

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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