Elisabeth Scheidl - Consultant

Q: Where is Elisabeth based?

Elisabeth is based in Vienna, Austria and prefers 100% remote projects.

Q: What languages does Elisabeth speak?

Elisabeth speaks the following languages: German (Native), English (Advanced) .

Q: How many years of experience does Elisabeth have?

Elisabeth has at least 25 years of experience. During this time, Elisabeth has worked in at least 13 different roles and for 9 different companies . The average length of individual experience is 2 years and 11 months . Note that Elisabeth may not have shared all experience and actually has more experience.

Q: What is Elisabeth's latest experience?

Elisabeth's most recent position is Consultant at Elisabeth Scheidl Consulting e.U. .

Q: What companies has Elisabeth worked for in recent years?

In recent years, Elisabeth has worked for Elisabeth Scheidl Consulting e.U. and TRIO Translational Research in Oncology .

Q: Which industries is Elisabeth most experienced in?

Elisabeth is most experienced in industries like Pharmaceutical , Biotechnology , and Healthcare .

Q: Which business areas is Elisabeth most experienced in?

Elisabeth is most experienced in business areas like Quality Assurance (QA) , Project Management , and Research and Development (R&D) . Elisabeth also has some experience in Legal and Compliance , Operations , and Strategy and Planning .

Q: Which industries has Elisabeth worked in recently?

Elisabeth has recently worked in industries like Pharmaceutical , Biotechnology , and Healthcare .

Q: Which business areas has Elisabeth worked in recently?

Elisabeth has recently worked in business areas like Quality Assurance (QA) , Legal and Compliance , and Operations .

Recommended expert

Vienna, Austria

Experience

Jan 2024 - Present

2 years 2 months

Vienna, Austria

Consultant

Elisabeth Scheidl Consulting e.U.

All services are tailored and flexible to meet customer needs
High-quality and comprehensive QA services
Guidance and support to ensure compliance with all GCP, ICH, GDPR, and other regulatory requirements
Preparation and advice to ensure inspection readiness of clinical trials, involved personnel and related processes
Audits of processes and systems relevant to the successful conduct of clinical trials
Provision of outsourced data protection officer (DPO) services

Oct 2022 - May 2023

8 months

Managing Director, TRIO gGmbH

TRIO Translational Research in Oncology

German branch of the non-profit academic CRO; approx. 10 employees
Responsibilities as Managing Director according to German corporate law

May 2022 - May 2023

1 year 1 month

Vice President, QARA

TRIO Translational Research in Oncology

Non-profit academic CRO focusing on oncology (solid tumors); approx. 350 employees worldwide
Permanent member of the Senior Leadership Team (SLT), with a decisive and active role
Defining strategic direction according to TRIO core values, leadership and decision-making
Strategic oversight of Quality Assurance (QA) and Regulatory Affairs (RA) as well as Computer System Validation (CSV), including staff management, business planning, risk management
Contribution to ensuring the financial and organizational health of the organization
Active participation in developing and implementing the strategic business plan, communicating vision and priorities, motivating staff and fostering a culture of continuous improvement
Management of organizational change and identification of opportunities to improve the business model
Operational leadership tasks similar to Director QARA

Jan 2020 - Apr 2022

2 years 4 months

Edmonton, Canada

Director Quality Assurance & Regulatory Affairs (QARA)

TRIO Translational Research in Oncology

Non-profit academic CRO focusing on oncology (solid tumors); approx. 160 employees worldwide
Responsible for coordinating global strategic initiatives related to quality and regulatory matters
Oversight of QA, RA, and CSV activities, including relevant metrics
Leading the QARA team, including resource allocation, training, and mentoring
Overseeing the QMS, including review of controlled documents (e.g., policies, SOPs)
Supervising audit activities, including conducting internal and external audits
Managing sponsor audits and regulatory inspections
Monitoring the CAPA management process
Supervising data protection and data management, liaising with the data protection officer
Overseeing staff training in GCP and other regulations relevant to clinical trials, including data protection
Designated Disaster Recovery Lead for the QARA department
Acting as process/system owner for EQMS and other systems as needed
Restructuring the QMS to simplify procedures and achieve a leaner process landscape

Oct 2018 - Dec 2019

1 year 3 months

Vienna, Austria

Clinical Quality Assurance Manager

AFFiRiS AG

Biotechnology company (development of antigen-specific vaccines for prevention and treatment of chronic diseases); approx. 24 employees
Responsible for clinical quality assurance and the QMS, managing clinical service providers including their qualification, and identifying and establishing continuous improvement of internal processes and procedures
Designing, preparing, and implementing a new SOP system for clinical research and development, focusing on management procedures and sponsor oversight processes required by ICH GCP E6(R2)

Sep 2015 - Jun 2018

2 years 10 months

Düsseldorf, Germany

Director Corporate Quality Assurance & Compliance Officer

ARENSIA Exploratory Medicine GmbH

Maintenance and continuous improvement of the company-wide QA system; CAPA management including root cause analysis, risk management, and audit program; oversight of regional quality assurance at all subsidiaries
Conducting internal and external audits
Compliance responsibility as delegated by management; development and implementation of policies and procedures to meet compliance expectations; streamlining compliance processes in regional subsidiaries
Managing the QA and compliance team (5 members)
Participation in strategic decision-making processes related to quality assurance and compliance matters
Involvement in strategic business planning related to clinical and project operations
Successfully implemented a compliance management system that led to 100% pass rate in sponsor-conducted compliance audits
Development of QA staff into qualified auditors (internal and external)
Contributed to the successful establishment of the Ukrainian subsidiary
Gained competence to participate in relevant decisions of the company board
Served as an expat at the Bucharest, Romania branch to handle regional quality assurance tasks (November 2017 – June 2018)

Jan 2013 - Aug 2015

2 years 8 months

Düsseldorf, Germany

International Quality Assurance Manager

ARENSIA Exploratory Medicine GmbH

Quality management and quality assurance, with functional management of regional QA staff
Conducting internal and external audits (study audits, system audits, and supplier qualification audits)
Providing guidance and training on regulations and policies for staff
Capacity building: training regional QA staff on GCP-related topics and auditing
Design, development, and implementation of a new quality management system; initiation of systematic risk mitigation by establishing a metrics trending system followed by a risk assessment that resulted in a 100% pass rate in sponsor qualification audits with no major or critical findings; successful setup of a subsidiary in Georgia; establishment of a GCP auditing service group at ARENSIA as an independent service

Sep 2012 - Jan 2013

5 months

Monheim am Rhein, Germany

Senior Clinical Quality Assurance Associate

UCB Biosciences GmbH

Pharmaceutical company with approx. 8,900 employees worldwide

Nov 2009 - Jun 2012

2 years 8 months

Cologne, Germany

Quality Assurance Manager/Auditor GCP

ITECRA GmbH & Co. KG

The company was closed due to insolvency.

Oct 2008 - Oct 2009

1 year 1 month

Cologne, Germany

Project Management/Internal Monitoring

ITECRA GmbH & Co. KG

Phase I & IIa studies

Dec 2005 - Sep 2008

2 years 10 months

Munich, Germany

Clinical Project Assistant

Hexal Biotech ForschungsGmbH

Phase I and III studies in pediatric endocrinology and biosimilars

May 2005 - Nov 2005

7 months

Vienna, Austria

Clinical Operation Assistant

ASSIGN Clinical Research GesmbH

Phase III studies in pediatric endocrinology

Jan 2000 - Dec 2005

6 years

Vienna, Austria

Study Coordinator CRO

VCC – medical allergy research

Phase II - IV allergy studies

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (23.5 years), Biotechnology (6.5 years), and Healthcare (2 years).

Pharmaceutical

Biotechnology

Healthcare

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (15 years), Project Management (10 years), Research and Development (10 years), Legal (7 years), Operations (1.5 years), and Strategy (1 year).

Quality Assurance

Project Management

Research and Development

Legal

Operations

Strategy

Summary

An expert in clinical research with many years of experience (since 2000) and a strong understanding of high quality requirements. The ability to think process-oriented and interdisciplinary has led to a professional specialization in quality assurance and quality management. For 15 years in a quality assurance role, the last years in leadership positions, including experience in remote management of intercultural teams.

Extensive auditing experience (more than 60 investigator site audits, more than 60 supplier qualification audits as well as document audits (about 15, mainly clinical study reports and informed consent forms) and internal system audits (about 10)).
Comprehensive knowledge of conducting early-phase clinical studies (Phase I – II), including first-in-human studies.
Successful development and implementation of quality management and compliance management systems for R&D departments in several companies.
Experience in setting up clinical trial sites from scratch, including implementing processes and training staff on clinical trials in ICH GCP, relevant laws and regulations, data protection issues, GDPR, etc.
Participation in intercultural business relationships and remote leadership of intercultural teams.

Continuous development of interpersonal skills towards a strong and leading leadership role with employees and colleagues. Communication with management is always proactive to ensure timely and targeted changes and adjustments of strategies and systems. In addition, a well-organized way of working with an attitude that is always focused on meeting deadlines and delivering excellent quality.

Skills

Areas Of Expertise

Clinical Trials
Quality Management Systems
Written Procedures And Sops
Ich Gcp
Quality Assurance
Auditing
Personal Data Protection & Gdpr Tailored To Clinical Research
Training Of Employees In Topics Mentioned

General Service Description

All Services Are Tailored And Flexible To Meet Customer Needs
High-quality And Comprehensive Qa Services
Guidance And Support To Ensure Compliance With Ich, Gcp, Gdpr & Other Regulatory Requirements
Preparation And Advice To Ensure Inspection Readiness Of Trials, Personnel And Relevant Processes
Audits Of Processes And Systems That Are Relevant For The Successful Execution Of Clinical Trials
Providing The Services Of An Outsourced Data Protection Officer (Dpo) Acc. To Gdpr

Qa Services And Consultancy

Creation And Set-up Of An Efficient And Risk-based Quality Management System (Qms) For Clinical Trials
Creation And Revision Of Respective Sops And Other Written Instructions
Creation And Set-up Of An Efficient Compliance Management System (Cms) Relevant For Clinical Trials, Including Implementation Of A Robust Process To Manage Potential Compliance Risks
Creation And Set-up Of Processes To Support Compliance With Gdpr In Clinical Trials Throughout All Relevant Aspects, I.e., Contracting, Data Collection, Processing And Storage, Awareness Trainings Etc.
Guidance And Support For Senior Management To Make Robust Decisions In Qa- And Compliance-related Questions And Topics
Assessment Of Already Existing Qms Including Proposed Possible Improvements Of Qms And Support In Implementing Those Changes As Well As Troubleshooting In Case Of Potentially Emerging Quality Issues

Audit Services For Clinical Trials

Investigator Site Audits
Vendor Qualification Audits For Clinical Providers (E.g., Cros, Imaging Facilities, Archives), Including Audits Of Clinical Safety Laboratories Under Gclp, If Applicable
Document Audits Of Relevant Essential Documents, Such As Trial Protocol, Patient Informed Consent, Clinical Trial Report, Etc., And The Trial Master File (Tmf) Before, During The Trial And/or Prior To Long-term Archiving
Inspection Readiness Visits At Investigator Sites And Internal Mock Inspections

Trainings

Training Of Personnel In Ich Gcp E6 (Latest Version)
Training On Quality Expectations And Compliance In Clinical Trials
Training On Inspection Readiness
Training On Data Protection Awareness And Compliance With Focus On Eu Gdpr In Clinical Trials
Other Trainings As Required In Above-mentioned Topics

Languages

German

Native

English

Advanced

Education

Mar 2000 - Jun 2000

University of Manchester

Exchange studies (ERASMUS-Program) · Manchester, United Kingdom

University for Continuing Education

MSc EU Regulatory Affairs · EU Regulatory Affairs · Krems an der Donau, Austria

University of Cologne

Dr. rer. medic., Pharmacology · Pharmacology · Cologne, Germany

...and 1 more

Certifications & licenses

Certified Data Protection Officer according to GDPR

Profile

Created

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Elisabeth based?

Elisabeth is based in Vienna, Austria and prefers 100% remote projects.

What languages does Elisabeth speak?

Elisabeth speaks the following languages: German (Native), English (Advanced).

How many years of experience does Elisabeth have?

Elisabeth has at least 25 years of experience. During this time, Elisabeth has worked in at least 13 different roles and for 9 different companies. The average length of individual experience is 2 years and 11 months. Note that Elisabeth may not have shared all experience and actually has more experience.

What roles would Elisabeth be best suited for?

Based on recent experience, Elisabeth would be well-suited for roles such as: Consultant, Managing Director, TRIO gGmbH, Vice President, QARA.

What is Elisabeth's latest experience?

Elisabeth's most recent position is Consultant at Elisabeth Scheidl Consulting e.U..

What companies has Elisabeth worked for in recent years?

In recent years, Elisabeth has worked for Elisabeth Scheidl Consulting e.U. and TRIO Translational Research in Oncology.

Which industries is Elisabeth most experienced in?

Elisabeth is most experienced in industries like Pharmaceutical, Biotechnology, and Healthcare.

Which business areas is Elisabeth most experienced in?

Elisabeth is most experienced in business areas like Quality Assurance (QA), Project Management, and Research and Development (R&D). Elisabeth also has some experience in Legal and Compliance, Operations, and Strategy and Planning.

Which industries has Elisabeth worked in recently?

Elisabeth has recently worked in industries like Pharmaceutical, Biotechnology, and Healthcare.

Which business areas has Elisabeth worked in recently?

Elisabeth has recently worked in business areas like Quality Assurance (QA), Legal and Compliance, and Operations.

What is Elisabeth's education?

Elisabeth holds a Doctorate in Pharmacology from University of Cologne, a Master in EU Regulatory Affairs from University for Continuing Education and a Master in Zoology/Biology from University of Vienna.

Does Elisabeth have any certificates?

Elisabeth has 1 certificate: Certified Data Protection Officer according to GDPR.

What is the availability of Elisabeth?

Elisabeth is immediately available part-time for suitable projects.

What is the rate of Elisabeth?

Elisabeth's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.