Senior Clinical Research Associate (Sr CRA II) at Thermo Fisher Scientific

Copenhagen, Denmark

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification (equivalency of appropriate education, training and/or directly related experience may be considered)
Valid driver's license
Effective clinical monitoring skills with at least 5 years of monitoring experience
Effective oral and written communication skills in Danish and English with the ability to communicate optimally with medical personnel and colleagues
Ability to travel and perform 8 days on site per month on average

Responsibilities

Performs and coordinates all aspects of the clinical monitoring and site management process in compliance with the Regulatory approved Protocol and Monitoring Plan
Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation
Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.)
Develops collaborative relationships with investigational sites
Acts as a site Manager and processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability
Ensures audit/Inspection readiness
Detailed tasks and responsibilities assigned to role are outlined in the task matrix

Skills

Clinical Research

CRA

Clinical Trials

Study Startup

Study Monitoring

Study Closeout

Patient Recruitment

Data Management

Clinical Operations

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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