Elisabeth (Mag.a dr. msc) Scheidl
Consultant
Experience
Jan 2024 - Present
2 years 1 monthVienna, 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 monthsManaging 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 monthVice 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 monthsEdmonton, 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 monthsVienna, 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 monthsDüsseldorf, 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 monthsDüsseldorf, 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 monthsMonheim 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 monthsCologne, Germany
Quality Assurance Manager/Auditor GCP
ITECRA GmbH & Co. KG
- The company was closed due to insolvency.
Oct 2008 - Oct 2009
1 year 1 monthCologne, Germany
Project Management/Internal Monitoring
ITECRA GmbH & Co. KG
- Phase I & IIa studies
Dec 2005 - Sep 2008
2 years 10 monthsMunich, Germany
Clinical Project Assistant
Hexal Biotech ForschungsGmbH
- Phase I and III studies in pediatric endocrinology and biosimilars
May 2005 - Nov 2005
7 monthsVienna, Austria
Clinical Operation Assistant
ASSIGN Clinical Research GesmbH
- Phase III studies in pediatric endocrinology
Jan 2000 - Dec 2005
6 yearsVienna, Austria
Study Coordinator CRO
VCC – medical allergy research
- Phase II - IV allergy studies
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
NativeEnglish
AdvancedEducation
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
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