Clinical Study Administrator - Hamburg based

ICON Strategic Solutions; Deutschland; Vor Ort; EUR 35.000 - 55.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Clinical Study Administrator to support the coordination and administration of study activities. This role involves ensuring quality and consistency in study deliverables, managing documentation, and interfacing with various stakeholders. The ideal candidate will possess strong organizational and administrative skills, along with proficiency in both German and English. Join a dynamic team committed to excellence in clinical studies and contribute to impactful research in the medical field.

Qualifikationen

• High school qualifications supporting skills for the position.
• Previous administrative experience in the medical/life sciences field.

Aufgaben

• Assist in the preparation and tracking of documents for the application process.
• Ensure compliance with local, national, and regional legislation.

Kenntnisse

Organizational Skills

Administrative Skills

Computer Proficiency

German Language

English Language

Ausbildung

High School/Secondary School Qualifications

Jobbeschreibung

The Clinical Study Administrator (CSA) assists in the coordination and administration of study activities from start-up to execution and close-out, within the Local Study Team (LST), to ensure quality and consistency of interventional study deliverables regarding time, cost, and quality objectives.

Responsibilities include:

1. Collecting, assisting in the preparation, reviewing, and tracking of documents for the application process, as well as coordinating and tracking study materials and equipment.
2. Assisting in the submission of proper application/documents to EC/IRB and, where appropriate, to Regulatory Authorities.
3. Interfacing with Investigators, external service providers, and CRAs during the document collection process.
4. Serving as the local administrative main contact, working closely with CRAs and/or LSAD throughout the study.
5. Setting up and maintaining the local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
6. Ensuring essential documents are uploaded timely to maintain eTMF “Inspection Readiness” and that study documents are prepared for final archiving and completion of the local eTMF, supporting CRA in close-out activities for the ISF.
7. Supporting contract preparation at the site level, where applicable.
8. Leading practical arrangements and contributing to the preparation of internal and external meetings, including printing, distributing documents, and archiving related emails.
9. Interfacing with Data Management Centre and/or Data Management, Global Clinical Solutions teams to facilitate the delivery of study-related documents/materials.
10. Ensuring compliance with local, national, and regional legislation, as applicable.

Minimum qualifications include:

• High school/Secondary school qualifications supporting skills and capabilities for the position.
• Previous administrative experience, preferably in the medical/life sciences field.
• Proven organizational and administrative skills.
• Computer proficiency.
• Good knowledge of spoken and written German and English.