d), preferable based in Hamburg at IQVIA

Frankfurt, Hessen, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 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
Preferable 2 years or more of experience as Clinical Trials Assistant or in another administrative role in clinical research, e.g. as Project Assistant; At least 3 years experience as working student in the field of clinical research
Excellent 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 and to maintain effective working relationships with coworkers, managers and clients
Flexibility to visit our client's office for meetings in the Hamburg area on regular basis, about 2-3 days/week or according to an agreed schedule
Preferable based in Hamburg

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
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

TMFCRFCRA SupportRSUClinical DocumentationData ManagementClinical Trial SuppliesQuery ManagementSite VisitsDocument Archiving

Questions & Answers

Common questions about this position

Is this a remote position or does it require office work?

The role is full-time with a combination of office and home-office, preferable in the Hamburg area, with flexibility to visit the client's office for meetings about 2-3 days per week or according to an agreed schedule.

What experience and education are required for this Clinical Trials Assistant role?

A Bachelor’s or higher degree in life sciences is preferable, or a High School Diploma with apprenticeship in life sciences, medical, pharmaceutical field, or office management. Preferable 2+ years as Clinical Trials Assistant or similar, or at least 3 years as a working student in clinical research.

What skills are essential for this position?

Candidates need excellent knowledge of GCP and ICH guidelines, fluent German at C1 level and good English, computer skills in Microsoft Word, Excel, and PowerPoint, plus effective communication, organizational, planning skills, and ability to work independently.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Experienced Clinical Trials Assistant position?

Strong candidates have a life sciences background, 2+ years of direct clinical trials assistant experience or 3+ years as a working student in clinical research, fluency in German (C1) and English, GCP/ICH knowledge, and proven organizational and communication skills.

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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