Klinisches Monitoring und Site Management
Aktualisiert am 05.11.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 10.11.2024
Verfügbar zu: 80%
davon vor Ort: 60%
ICH-GCP
Site Management
Clinical Reserach
CTMS
Oncology
Hämatooncology
Cardiology
EDC
Immunology
Neurology
Monitoring
Remote Monitoring
Kommunikationsstärke
Analysefähigkeit
German
Native
English
Fluent

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 Jahr 2 Monate
2023-10 - heute

Monitoring of phase III clinical trials

Contract Clinical Research Associate
Contract Clinical Research Associate
  • Monitoring of phase III clinical trials in the field of Immunology: Responsible for all aspects of site management from site initiation to site close out; Conduct of site visits (SIV, IMV, COV) and remote monitoring; Train site staff in all study related processes e.g. clinical protocol, CRF and good clinical practice ICH/GCP
  • Remote monitoring of an observational cohort study in the field of orthopedics (Patella implant)
2 Jahre 9 Monate
2021-01 - 2023-09

Supervision of national and international phase II-III clinical trials

Clinical Research Associate
Clinical Research Associate
  • Supervision of national and international phase II-III clinical trials according to the German Medicines Act (AMG) as Lead CRA and CRA
  • Planning, organizing and conducting monitoring visits (SQV, SIV, IMV and COV), onsite and remote
  • Study-specific training of CRA team colleagues and study personnel
  • Creation and review of monitoring documents and review of key study documents
CTC North GmbH
Hamburg
9 Monate
2008-03 - 2008-11

Conception, creation, validation and optimization of controlled systems

Development Engineer
Development Engineer

As part of the new development of a vacuum therapy system:

  • Conception, creation, validation and optimization of controlled systems
  • Technical supervision of the construction and commissioning of tests and prototypes
VCS Medical Technology
Hamburg

Aus- und Weiterbildung

Aus- und Weiterbildung

2 Jahre 10 Monate
2017-10 - 2020-07

Studies of Biology

Master of Science in Biology | Grade: 1.1, University of Hamburg, Germany
Master of Science in Biology | Grade: 1.1
University of Hamburg, Germany
3 Jahre 6 Monate
2014-10 - 2018-03

Studies of Biology

Bachelor of Science in Biology | Grade: 1.6, University of Hamburg, Germany
Bachelor of Science in Biology | Grade: 1.6
University of Hamburg, Germany
4 Jahre 1 Monat
2004-03 - 2008-03

Studies of Biomedical Engineering

Graduate engineer (Dipl. Ing.) | Grade: 1.7, University of Applied Sciences Hamburg, Germany
Graduate engineer (Dipl. Ing.) | Grade: 1.7
University of Applied Sciences Hamburg, Germany

Kompetenzen

Kompetenzen

Top-Skills

ICH-GCP Site Management Clinical Reserach CTMS Oncology Hämatooncology Cardiology EDC Immunology Neurology Monitoring Remote Monitoring Kommunikationsstärke Analysefähigkeit

Produkte / Standards / Erfahrungen / Methoden

COMPUTER SKILLS

MS Office:

  • Word
  • PowerPoint
  • Excel
  • Outlook


EDC systems:

  • secuTrial
  • Marvin EDC
  • SMART-TRIAL


CTMS systems:

  • SimpleTrials


Statistical software:

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 Jahr 2 Monate
2023-10 - heute

Monitoring of phase III clinical trials

Contract Clinical Research Associate
Contract Clinical Research Associate
  • Monitoring of phase III clinical trials in the field of Immunology: Responsible for all aspects of site management from site initiation to site close out; Conduct of site visits (SIV, IMV, COV) and remote monitoring; Train site staff in all study related processes e.g. clinical protocol, CRF and good clinical practice ICH/GCP
  • Remote monitoring of an observational cohort study in the field of orthopedics (Patella implant)
2 Jahre 9 Monate
2021-01 - 2023-09

Supervision of national and international phase II-III clinical trials

Clinical Research Associate
Clinical Research Associate
  • Supervision of national and international phase II-III clinical trials according to the German Medicines Act (AMG) as Lead CRA and CRA
  • Planning, organizing and conducting monitoring visits (SQV, SIV, IMV and COV), onsite and remote
  • Study-specific training of CRA team colleagues and study personnel
  • Creation and review of monitoring documents and review of key study documents
CTC North GmbH
Hamburg
9 Monate
2008-03 - 2008-11

Conception, creation, validation and optimization of controlled systems

Development Engineer
Development Engineer

As part of the new development of a vacuum therapy system:

  • Conception, creation, validation and optimization of controlled systems
  • Technical supervision of the construction and commissioning of tests and prototypes
VCS Medical Technology
Hamburg

Aus- und Weiterbildung

Aus- und Weiterbildung

2 Jahre 10 Monate
2017-10 - 2020-07

Studies of Biology

Master of Science in Biology | Grade: 1.1, University of Hamburg, Germany
Master of Science in Biology | Grade: 1.1
University of Hamburg, Germany
3 Jahre 6 Monate
2014-10 - 2018-03

Studies of Biology

Bachelor of Science in Biology | Grade: 1.6, University of Hamburg, Germany
Bachelor of Science in Biology | Grade: 1.6
University of Hamburg, Germany
4 Jahre 1 Monat
2004-03 - 2008-03

Studies of Biomedical Engineering

Graduate engineer (Dipl. Ing.) | Grade: 1.7, University of Applied Sciences Hamburg, Germany
Graduate engineer (Dipl. Ing.) | Grade: 1.7
University of Applied Sciences Hamburg, Germany

Kompetenzen

Kompetenzen

Top-Skills

ICH-GCP Site Management Clinical Reserach CTMS Oncology Hämatooncology Cardiology EDC Immunology Neurology Monitoring Remote Monitoring Kommunikationsstärke Analysefähigkeit

Produkte / Standards / Erfahrungen / Methoden

COMPUTER SKILLS

MS Office:

  • Word
  • PowerPoint
  • Excel
  • Outlook


EDC systems:

  • secuTrial
  • Marvin EDC
  • SMART-TRIAL


CTMS systems:

  • SimpleTrials


Statistical software:

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