Experienced Clinical Trials Assistant (m/w/d), home based

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas. You will be involved in data management, creation of study related documents and correspondence with internal departments, research sites and our client to ensure a complete and accurate Trial Master File delivery.

We currently offer the exciting opportunity to join the FSP team as Experienced Clinical Trials Assistant (m/w/d) in full-time and work home-based in Germany.

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.

REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE

• 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.
• At least 1 year of experience as Clinical Trials Assistant or in another administrative role in clinical research, e.g. as Project Assistant.
• Excellent knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Fluent languages 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.

Please apply with your English CV and motivation letter.