Elisabeth S.-Consultant
Check rate
Experience
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, the personnel involved and related processes
- Audits of processes and systems relevant to the successful conduct of clinical trials of pharmaceuticals and medical devices
- Providing the services of an outsourced data protection officer (DPO)
Managing Director TRIO gGmbH
TRIO Translational Research in Oncology
- German subsidiary of the non-profit academic CRO; approximately 10 employees
- Responsibilities as managing director under German corporate law
Vice President, QARA
TRIO Translational Research in Oncology
- Non-profit academic CRO focused on oncology (solid tumors); approximately 350 employees worldwide
- Permanent member of the Senior Leadership Team (SLT), with a key and active role
- Setting the strategic direction in line with TRIO's core values, leadership and decision-making
- Strategic oversight of Quality Assurance (QA), Regulatory Affairs (RA) and Computerized System Validation (CSV), including people management, business planning and risk management
- Contributing to the financial and organizational health of the organization
- Actively participating in the development and implementation of the strategic corporate plan, communicating the vision and priorities, motivating employees and promoting a culture of continuous improvement
- Managing change across the company and identifying opportunities to improve the business model
- Operational leadership responsibilities similar to those of Director QARA
Director Quality Assurance & Regulatory Affairs (QARA)
TRIO Translational Research in Oncology
- Non-profit academic CRO focused on oncology (solid tumors); approximately 160 employees worldwide
- Responsible for coordinating global strategic activities related to quality and regulatory matters
- Oversight of QA, RA and CSV activities, including applicable metrics
- Managing the QARA team, including resourcing, training and mentoring
- Oversight of the QMS, including review of controlled documents (e.g. policies, SOPs)
- Oversight of audit activities, including conducting internal and external audits
- Managing sponsor audits and regulatory authority inspections
- Oversight of CAPA management
- Oversight of data protection and data management, and liaison with the data protection officer
- Oversight of staff training in GCP and regulations relevant to clinical trials, including data protection
- Designated Disaster Recovery Lead for the QARA department
- Process/system owner for EQMS and other systems as needed
- Restructured the QMS with a focus on simplifying procedure descriptions to create a leaner process landscape
Clinical Quality Assurance Manager
AFFiRiS AG
- Biotechnology company (developing antigen-specific vaccines to prevent and treat chronic diseases); 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
- Designed, prepared and implemented a new SOP system for clinical research and development, focused on management procedures and sponsor oversight processes required under ICH GCP E6(R2)
Director Corporate Quality Assurance & Compliance Officer
ARENSIA Exploratory Medicine GmbH
CRO, privately owned company specializing in early-phase clinical trials in patients; approximately 200 employees, operational sites in several European countries (Germany, Romania, Republic of Moldova, Lithuania, Georgia, Ukraine)
Quality Assurance:
- Maintaining and continuously improving the company-wide QA system; CAPA management, including root cause analysis, risk management and audit program; overseeing quality assurance at the regional level across all subsidiaries;
- Conducting internal and external audits
Compliance:
- Compliance responsibility as delegated by senior management; developing and implementing policies and procedures to meet compliance expectations; streamlining compliance processes at regional subsidiaries;
Leadership responsibilities:
- Managing the QA and Compliance group (5 employees)
- Participating in strategic decision-making related to quality assurance and compliance matters
- Participating in strategic company planning related to clinical and project operations
Achievements:
- Successfully implementing a compliance management system, resulting in a 100-percent pass rate in sponsor-conducted compliance audits
- Developing QA staff into qualified auditors (internal and external)
- Contributing to the successful establishment of the Ukrainian subsidiary
- Gaining the skills to contribute to relevant company board decisions
- Working as an expat at the Bucharest, Romania, office to take on regional quality assurance responsibilities (November 2017 – June 2018)
International Quality Assurance Manager
ARENSIA Exploratory Medicine GmbH
CRO, privately owned company specializing in early-phase clinical trials in patients; approximately 160 employees, operational sites in several European countries (Germany, Romania, Republic of Moldova, Lithuania, Georgia)
- Quality management and quality assurance; functional leadership of regional QA staff; conducting internal and external audits (study audits, system audits and vendor qualification audits); providing staff with guidance and training on regulations and policies
- Capacity building: training regional QA staff on GCP-related topics and auditing
Achievements:
- Designing, creating and implementing a new quality management system
- Initiating systematic risk reduction by setting up a metrics trending system, followed by a risk assessment that resulted in a 100-percent pass rate in sponsor qualification audits with no major or critical findings
- Successfully establishing a subsidiary in Georgia
- Establishing a GCP inspection services group at ARENSIA as a standalone service
Senior Clinical Quality Assurance Associate
UCB Biosciences GmbH
- Pharmaceutical company, approximately 8,900 employees worldwide
Quality Assurance Manager/Auditor GCP
ITECRA GmbH & Co. KG
- The company closed due to insolvency.
Project Management/Internal Monitoring
ITECRA GmbH & Co. KG
- Phase I & IIa studies
Clinical Project Assistant
Hexal Biotech ForschungsGmbH (subsidiary of Novartis)
- Phase I and III studies in pediatric endocrinology and biosimilars
Clinical Operation Assistant
ASSIGN Clinical Research GesmbH
- Phase III studies in pediatric endocrinology
Study Coordinator CRO
VCC – medical allergy research
- Phase II - IV allergy studies
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Pharmaceutical, Healthcare, and Biotechnology.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Project Management, Research and Development, Legal, Audit, and Operations.
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 in a process-oriented and interdisciplinary way has led to professional specialization in quality assurance and quality management. 15 years in quality assurance roles, including leadership roles in recent years and experience in the remote management of intercultural teams.
- Extensive auditing experience (more than 70 investigator site audits in pharmaceuticals and medical devices, more than 70 supplier qualification audits, document audits (approx. 15, mainly clinical study reports and informed consent forms) and internal system audits (approx. 10).
- Comprehensive knowledge of conducting early-phase clinical trials (Phase I – II), including First-In-Men studies.
- Successfully developed and implemented quality management and compliance management systems for R&D departments in several companies.
- Experience building clinical trial centers from the ground up, including implementing processes and training clinical trial staff on ICH GCP, relevant laws and regulations, data protection matters, GDPR, etc.
- Worked in intercultural business relationships and led (remotely) intercultural teams.
Continuously developing people skills toward a strong leadership role with employees and colleagues. Communication with management is always proactive, with the goal of making timely, targeted changes and adjustments to strategies and systems. In addition, I work in a well-organized way and always aim to meet deadlines and deliver excellent quality.
Skills
Areas Of Expertise
- Clinical Trials
- Quality Management Systems
- Written Procedures And Sops
- Ich Gcp (Qms) And Sops
- Quality Assurance
- Auditing
- Personal Data Protection & Gdpr Tailored To Clinical Research
- Training Of Employees In The 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 And Regulatory Requirements
- Preparation And Advice To Ensure Inspection Readiness Of Clinical Trials, Personnel And Related Processes
- Audits Of Processes And Systems Relevant To The Successful Conduct Of Clinical Trials
- Providing The Services Of An Outsourced Data Protection Officer (Dpo) In Accordance With Gdpr
Qa Services And Consultancy
- Creation And Set-Up Of An Efficient And Risk-Based Qms For Clinical Trials
- Creation And Revision Of Relevant Sops And Other Written Instructions
- Creation And Set-Up Of An Efficient Cms For Clinical Trials, Including Implementation Of A Robust Process To Manage Potential Compliance Risks
- Creation And Set-Up Of Processes To Support Gdpr Compliance In Clinical Trials Across All Relevant Aspects
- Guidance And Support For Senior Management To Make Well-Informed Decisions On Qa- And Compliance-Related Questions And Topics
- Assessment Of An Existing Qms, Including Suggestions For Possible Improvements And Support In Implementing These Changes, As Well As Troubleshooting Potential Quality Issues
Audit Services For Clinical Trials
- Investigator Site Audits
- Vendor Qualification Audits For Clinical Providers (E.G. Cros, Clinical Safety Laboratories, Imaging Facilities, Archives)
- Document Audits Of Relevant Essential Documents, Such As The Trial Protocol, Informed Consent Form, Clinical Study Report, Etc., And The Trial Master File (Tmf) Before And During The Trial And/Or Before Long-Term Archiving
- On-Site Inspection Preparation 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 A Focus On Gdpr In Clinical Trials
- Other Training As Required In The Topics Mentioned Above
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
Education
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
University of Manchester
Exchange studies (ERASMUS-Program) · Manchester, United Kingdom
Certifications & licenses
Training on ISO 14155:2026
Training on ICH E6 GCP Revision 3
Certified Data Protection Officer under the GDPR
Conscious Leadership Training Program
Whitebox
Compliance Officer Training
Management Circle
Practical GCP Compliance, Auditing of Trials & Systems
DIA
Training and updates on ICH E6 GCP and ISO 14155
Statistics
Experience
Global experience
Expertise
Qualifications
Frequently asked questions
Have questions? Find more information here.
Elisabeth is based in Vienna, Austria and prefers 100% remote projects.
Elisabeth speaks the following languages: German (Native), English (Advanced).
Elisabeth has at least 26 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. Note that Elisabeth may not have shared all experience and actually has more experience.
Based on recent experience, Elisabeth would be well-suited for roles such as: Consultant, Managing Director TRIO gGmbH, Vice President, QARA.
Elisabeth's most recent position is Consultant at Elisabeth Scheidl Consulting e.U..
In recent years, Elisabeth has worked for Elisabeth Scheidl Consulting e.U. and TRIO Translational Research in Oncology.
Elisabeth is most experienced in industries like Pharmaceutical, Healthcare, and Biotechnology.
Elisabeth is most experienced in business areas like Quality Assurance, Project Management, and Research and Development. Elisabeth also has some experience in Legal, Audit, and Operations.
Elisabeth has recently worked in industries like Pharmaceutical and Healthcare.
Elisabeth has recently worked in business areas like Quality Assurance, Legal, and Audit.
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.
Elisabeth has 7 certificates. Among them, these include: Training on ISO 14155:2026, Training on ICH E6 GCP Revision 3, and Certified Data Protection Officer under the GDPR.
Elisabeth will be available part-time from January 2027.
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Average rates for similar positions
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The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 14 Nov 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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