# Marion Wendt – Freelance Senior Clinical Research Associate

> English machine-readable version of Marion Wendt's professional website.

- Language: English (`en`)
- Canonical HTML page: https://www.marionwendt.de/index_en.html
- German version: https://www.marionwendt.de/index.md
- Underlying website last updated: October 2026

The canonical HTML page is the authoritative version. It also contains the contact form, full imprint and full privacy notice.

## Profile

Marion Wendt completed additional training as a Clinical Research Associate in 1993 and subsequently gained hands-on experience with a CRO and a sponsor. She has worked as a freelance Senior Clinical Research Associate since June 1997.

Her experience includes multicentre and multinational Phase I–IV pharmaceutical trials, post-marketing studies and clinical investigations of medical devices. She works in Germany and abroad as well as on-site at clients and speaks fluent English.

## Clinical research services

- Budget planning and tracking
- Review of protocols and CRFs as well as CRF creation
- Creation of patient information and informed-consent documents
- Creation of study-specific documents
- Investigator recruitment and selection of trial sites
- Site qualification visits and site initiations
- Support with ethics and authority submissions
- On-site and remote monitoring
- Co-monitoring and QC co-monitoring
- Coaching and mentoring of trial sites and CRAs
- Site closure visits
- Project management and query resolution
- Trial Master File review at the sponsor
- Organisation and realisation of investigator meetings
- Preparation of audits and inspections as well as participation and follow-up

Activities are conducted according to applicable regulations and recommendations and the clients' SOPs, including AMG, the GCP Regulation, ICH GCP, MPG and ISO 14155.

## Education and career

- 2007–2008: Subject Specialist Clinical Research modular training at FORUM Institut für Management GmbH
- 2004: Examination in expert knowledge for retail trade in over-the-counter medicines according to section 50 of the German Drug Law
- 1992–1993: Vocational training as a Clinical Research Associate at Institut für Klinische Pharmakologie Bobenheim, Prof. Dr. Lücker GmbH, with the examination result “excellent”
- Since 06/1997: Freelance Senior Clinical Research Associate
- 1995–1997: Clinical Research Associate and Clinical Project Leader at Orion Pharma GmbH; Senior CRA and Head of Monitoring from January 1996
- 1992–1995: Clinical Research Associate and Clinical Project Leader at Institut für Klinische Pharmakologie Bobenheim, Prof. Dr. Lücker GmbH

## Key experience

- Setting up a clinical research department
- CRA training and ICH GCP training
- Budget planning and tracking
- Coaching and mentoring of trial sites and CRAs
- Co-monitoring and QC co-monitoring
- Electronic CRFs
- Ethics and authority submissions
- Clinical investigations of medical devices
- Monitoring and project management of multinational Phase I–IV studies
- Selection of investigational trial sites
- Trial Master File review at the sponsor
- Preparation and realisation of investigator meetings
- Preparation and support of audits and inspections

## Therapeutic experience

AIDS, allergology, cardiology, dermatology, diabetology, endocrinology, gastroenterology, gynaecology, haematology, hyperhidrosis, immunology, infectious diseases, intensive care, neurology, nutrition, obesity, oncology, ophthalmology, orthopaedics, pain, pneumonology, psychiatry, reproduction and transplantation.

## Professional training during the last ten years

- ISO 14155:2026, summary of the most important changes, GCP-Service International Ltd. & Co. KG, 06/2026
- MPDG supplementary training, GCP-Service International Ltd. & Co. KG, 01/2026
- WSG Symposium 2025, 11/2025
- GCP Refresher based on ICH E6(R3), Clinical Excellence GmbH, 05/2025
- MPDG Refresher Training, GCP-Service International Ltd. & Co. KG, 04/2024
- GCP Refresher Training, GCP-Service International Ltd. & Co. KG, 04/2024
- Symposium “Audits & Inspections”, DGPharMed, 01/2024
- Refresher Training GCP and Regulations, eurofins bioskin, 12/2022
- GCP Refresher Training, GCP-Service International Ltd. & Co. KG, 04/2022
- MPG Refresher/GCP Refresher, ARTIMED, 07/2021
- Workshop “Applied Course in Data Management”, AGAH e.V., 06/2021
- MDR Update Training, GCP-Service International Ltd. & Co. KG, 11/2020
- GCP Refresher Training, GCP-Service International Ltd. & Co. KG, 04/2020
- 5th European Conference on Clinical Research, EUCROF, 02/2020
- Seminar “Das neue Monitoring-Konzept für klinische Prüfungen”, FORUM, 09/2019
- MPG Refresher, FORUM, 11/2018
- GCP Update Course 2018, S. Zeller for bioskin GmbH, 11/2018
- 4th European Conference on Clinical Research, EUCROF, 02/2018
- Symposium “Audits & Inspektionen; Qualitätsmanagement at its best”, DGPharMed, 09/2017
- 3rd European Conference on Clinical Research, EUCROF, 10/2016
- GCP investigator refresher training, GCP-Service International Ltd. & Co. KG, 10/2016

## Contact and documents

- Email: cra@marionwendt.de
- Contact form: https://www.marionwendt.de/index_en.html#contact
- Short CV as PDF: https://www.marionwendt.de/cv/Wendt-Marion_Lebenslauf_EN.pdf
- Imprint and privacy notice: https://www.marionwendt.de/index_en.html#legal