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Arthur Steinmann

Clinical Research Associate / Consultant

Offenbach am Main, Deutschland

  • 50.1055
  • 8.761
  • Unverbindlicher Tarif 640€ / Tag
  • Berufserfahrung 7 Jahre und +
Projekt anbieten

Verfügbarkeit nicht bestätigt

In Teilzeit, 1 Tag die Woche

Auftragspräferenzen

Mobilität
Führt alle Aufträge im Homeoffice durch
Auftragsdauer
≥ 6 Monate
Branche
  • Forschung
  • Gesundheit & Wellness
  • Medizin
  • Pharmazeutische Industrie

Checkliste

  • Geprüfte E-Mail-Adresse
  • Die unterzeichnete Malt Freelancer Charta
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Fähigkeiten (6)

Arthur in wenigen Worten

Experienced Senior CRA and Consultant with over 13 years experience in clinical trials.
Freelancer (self employed) since Aug. 2013
Location: Germany

Monitoring and coordinating activities:

• set up activities
• management and setup of site agreements
• IRB / IEC submissions, local RA submissions, BfS submissions
• monitoring (pre trial, initiation, interim and closeout visits)
• TMF maintenance and audit preparation
• handling of patient reimbursements and site payments
• preparation of status reports
• handling of IP and non IP shipments
• coordination of general task to support the PM
• general consulting

Projekt- und Berufserfahrung

Juni 2010 - Juli 2013 | Offenbach am Main, Deutschland

Pharmazeutische Industrie

SIRO CLINPHARM GERMANY GMBH

Clinical Project Manager

Key Responsibilities

• Coordination and development of trial projects regarding agreed defaults and timelines
• Coordination of budgets, time lines, quality guidelines for projects, delivery of clinical trial supplies, payment of clinical grants etc.
• Supervision and coordination of submissions to authorities and IRBs/IECs, ensuring the accuracy and quality of regulatory data
• Tracking project activities and delegation to members of the project team
• Risk analysis of projects and making recommendations to improve time lines for project completion
• Compilation and maintenance of documentation for the project, e.g. Trial Master File, Management Plans
• Organising project meetings, e.g. investigator meeting, kickoff meeting, project meetings, teleconferences
• Coordination of collaboration among different departments involved in the project
  • Coordination
  • Organization
  • Delegation
  • Management
  • Support
  • Training
  • Study Coordination
August 2008 - Mai 2010 | Offenbach am Main, Deutschland

Pharmazeutische Industrie

SIRO Clinpharm Germany GmbH

Senior Clinical Research Associate

Experience

Monitoring and coordinating activities in neurology, dermatology and oncology fields, including

• set up activities
• feasibility conducts
• assistance in IRB / IEC submissions
• monitoring (pre trial, initiation, interim and closeout visits)
• TMF maintenance and audit preparation
• handling of patient reimbursements and site payments
• preparation of status reports
• assistance in medical review
• assistance in compilation of the final study report
• handling of IP and non IP shipments
• coordination of general task to support the PM
• conduct of trainings for employees
Juni 2004 - Juli 2008 | Offenbach am Main, Deutschland

Pharmazeutische Industrie

Omega Mediation GmbH & Co. KG, Clinical Research Services

Clinical Research Associate

• set up activities
• feasibility conducts
• assistance in IRB / IEC submissions
• monitoring (pre trial, initiation, interim and closeout visits)
• TMF maintenance
• coordination of general task to support the PM, preparation for site audits
  • Monitoring
  • Site Managment
  • Clinical Trial
  • Clinical Study
  • Regulatory
Juli 2003 - November 2003 | Bad Homburg vor der Höhe, Deutschland

Pharmazeutische Industrie

Chiltern International GmbH, Bad Homburg, Germany

Clinical Research Associate

Experience

• set up activities
• feasibility conducts
• assistance in IRB / IEC submissions
• TMF maintenance
• coordination of general task to support the PM
• documentation
  • Monitoring
  • site management
  • clinical trials
  • trial master file

Ausbildung & Abschlüsse

  • Biplom Biologe

    Johann Wolfgang Goethe-Universität Frankfurt

    2000

    Studium der Biologie mit Schwerpunkt Zoologie und Proteinbiochemie.

Sprachen

  • Deutsch

    Fließend/ Muttersprache

  • Englisch

    Verhandlungssicher

  • Französisch

    Grundkenntnisse

  • Russisch

    Grundkenntnisse

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