Clinical Trial Assistant at IQVIA

Copenhagen, Denmark

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

High School Diploma or equivalent
1 year administrative support experience
Equivalent combination of education, training and experience
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
Written and verbal communication skills - must be fluent in both English and local language
Effective time management and organizational skills
Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training
Knowledge of applicable protocol requirements as provided in company training

Responsibilities

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery
Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
Assist with periodic review of study files for completeness
Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training

Skills

Key technologies and capabilities for this role

Microsoft WordMicrosoft ExcelMicrosoft PowerPointTrial Master File (TMF)Good Clinical Practice (GCP)ICH guidelinesAdministrative SupportDocument ManagementClinical Trial DocumentationCase Report Forms (CRFs)

Questions & Answers

Common questions about this position

What qualifications are required for the Clinical Trial Assistant role?

A High School Diploma or equivalent is required, along with 1 year of administrative support experience or an equivalent combination of education, training, and experience. Candidates need computer skills in Microsoft Word, Excel, and PowerPoint, plus fluency in English and the local language.

What skills are essential for this position?

Key skills include effective time management, organizational skills, ability to establish and maintain effective working relationships, and awareness of Good Clinical Practice (GCP) and ICH guidelines as provided in company training.

Is the Clinical Trial Assistant position remote or office-based?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What experience makes a strong candidate for this Clinical Trial Assistant position?

Candidates with 1 year of administrative support experience, computer proficiency in Microsoft Office, strong communication and organizational skills, and familiarity with GCP and ICH guidelines from training will stand out.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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