Arthur Steinmann - Clinical Trials Services
Welcome to my Website. I'm an experienced Senior Clinical Research Associate / Consultant with over 18 years experience in clinical trials and offer various clinical research services.
Please see below my professional experience. I'm happy to answer to your inquiries. If you have specific questions regarding my service portfolio, feel free to contact me.
Professional Experience since 2003 (18 years)
Company: Freelancer (self-employed)
Job / Position: Senior Clinical Research Associate / Consultant
Self-employed since: August 2013 – recent
Location: Germany (Hessen)
Study Projects as Freelancer since 2013:
Acute ischemic Stroke - Clinical Study - (Phase Ib / IIa, ongoing)
Colorectal Cancer Clinical Study - (Phase III, ongoing)
Monotherapy / combined therapy in adv. stage / refractory cancer – Clin. Study (Phase I, ongoing)
Colorectal Cancer / Surgery - Clinical Study (Phase IIb, ongoing)
Radioactive Treatment of Hepatic Carcinoma / SIRT - Medical Device Study (completed)
Oncology - NSCLC - Immunotherapy - Clinical Study (completed)
Medical Device - Intensive Care - Cardiology - Medical Device Study (completed)
Non-Interventional - Late Phase - Venous Thrombosis - Clinical Study (completed)
Non-Interventional - Late Phase - Epidemiological Data Collection (completed)
Summary of available services
- General monitoring and coordinating activities
- Set up activities including feasibility and contract negotiations
- Submissions to IRB / IEC, competent and local autorities including BfS
- 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
- Translations of study documents
- General consulting
Previous professional Backgroun
Company: Siro Clinpharm Germany GmbH (CRO)
Employment Status: Employee
Title: Clinical Project Manager
Total of years: 3 years
Services performed:
- 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
- Safeguard the compliance to international regulations and safety standards, e.g. ICH / GCP, safety reporting timelines etc. …
Here you can download my current Curriculum Vitae.