d), Home Office at IQVIA

Frankfurt, Hessen, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

Bachelor’s or higher-level degree preferable in life science or High School Diploma and apprenticeship in life science, the medical or pharmaceutical field or office management
Previous work experience as Clinical Research Associate is required
Preferable administrative support experience in clinical research, e.g. as Clinical Trials Assistant, Study Start-Up Assistant
Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Fluent language skills in German on at least C1 level and good command of English
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
Effective communication, organizational and planning skills
Ability to work independently and to effectively prioritize tasks while working on multiple projects
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Flexibility to business travel - for CRA support and client meetings, in average 2-4 times per month

Responsibilities

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
Collaborate with clinical team on 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 and completeness
Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Coordinate 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
Occasionally conduct Site Qualification Visits or accompany CRAs to visits at study sites / hospitals and support with data review
Act as a mentor for less experienced Clinical Trial Coordinators and assist with training and onboarding of new colleagues
May serve as subject matter expert for business processes or lead Clinical Trial Coordinators study teams
May participate in departmental quality or process improvement initiatives

Skills

Clinical Trials

Trial Master File (TMF)

Clinical Documentation

Data Management

Case Report Forms (CRF)

Site Qualification Visits

Regulatory Compliance

Study File Review

Clinical Trial Supplies

CRA Support

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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