Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical Research Organization (CRO)Industries

Requirements

Candidates should possess a University degree in a science-related field and be CRA qualified as per the Ministerial Decree dated 15/11/2011, with a minimum of 3 years of independent monitoring experience in clinical development phases II-IV. They must demonstrate understanding of ICH-GCP, EU, and FDA requirements, along with fluency in English and Italian, and hold a valid Driver's License.

Responsibilities

The Senior CRA will monitor investigator sites using a risk-based approach, conducting root cause analysis and implementing corrective actions to ensure compliance and mitigate risks. They will ensure data accuracy through site visits and remote monitoring, assess investigational products, document observations in reports, escalate deficiencies, maintain contact with sites, participate in investigator payments, investigate findings, and contribute to the investigator payment process. Furthermore, they will initiate clinical trial sites, conduct file reviews, provide status updates, update study systems, and contribute to project publications and process improvement initiatives.

Skills

Risk-based monitoring
Root cause analysis (RCA)
Critical thinking
Problem-solving
Data review
CRF review
On-site monitoring
Remote monitoring
Investigator site assessment
Physical inventory management

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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