In-depth knowledge and experience in management of clinical studies, in pharma and hospital environment (+15 years) throughout all phases of drug development (phase I - IV) in matrix environment and for all stages in small and large pharma companies
7 years experience in early phase drug development including Entry into Human studies and in different therapeutic areas: Immunology: IBD, Hep.B /Oncology: different cancer types
7 years experience in large late stage (phase III and IV) studies in leading large global study teams in collaboration with CRO's and other vendors
Solid vendor alliance / relations management experience for global CRO, central laboratories and mobile nursing vendors at Roche
Knowledge in vendor partnership management has been gained in day to day business activities for clinical trials and in total 3 years "rotation" as a dedicated vendor and sourcing manager role within global environment
Experience in the set up of a fully outsourced working model with a CRO for early phase HV studies for Roche pRED (early phase study unit)
Chair of pan-Roche mobile nursing governance network (part time)
Member of pan-Roche CRO vendor governance network
Constant learning and improvement/ implementing innovative solutions
Consultancy and mentoring of team members
Outcome and solution oriented, self organized, agile, communicative, creative and innovative networker, leader and team player applying situational leadership
Overview
27
years of professional experience
Work History
F. Hoffmann-La Roche AG
Clinical Research Study Leader
08.2010 - Current
Job overview
Leading matrix teams with all aspects of international study management across all study phases and different indications (oncology, immunology) for insourced and outsourced studies
Risk assessment/RBQM
Budget /Timelines/Quality
Contracting
Vendor Management
Follow regulations: e.g. ICH-GCP, GDP
Participate audits/ CAPA resolution
Presenting at investigator meetings and other study related meetings and trainings
Disease areas: Oncology, Immunology (Hep B, IBD)
Experience in early phase CPU studies but also large late phase studies
F. Hoffmann-La Roche AG
Vendor Partnership Manager pRED
02.2024 - 03.2025
Job overview
Vendor relationship management: CROs and mobile nursing preferred vendors
Performance oversight of assigned vendors via KPIs and metrics
Liaise with vendor counterpart for Identification of issues and risks and resolution of these in close collaboration with internal as well as vendor functions
Audit/CAPA follow up with regards to vendor audits
Bridging the gap between sourcing and business (bring in experience from working as a study leader, sharing knowledge and providing meaningful input for vendor selection or sharing feedback from the study leader community when it comes to vendor related issues or special sourcing needs)
Involved in the set up of an E2E (fully outsourced) model for early phase CPU studies in Roche pRED
Head of the pan-Roche Mobile Nursing Governance Network since February 2024. Establish governance meetings, KPIs and quality oversight;
Member of the pan Roche CRO governance forum: streamline communication with key CRO partners across all business units; discuss issues affecting all business units with CRO partner and work on resolutions; constantly improve working relationships and processes to create efficiencies
F. Hoffmann-La Roche AG
Vendor Partnership Manager pRED
04.2020 - 01.2022
Job overview
Vendor relationship management: Central Lab (Q2S), CROs
Quality oversight, KPI oversight, escalation management, portfolio and resource oversight and planning
Follow up on audit findings / CAPAs with the vendors
Identifying gaps in processes and implementing process improvements
Communication to internal and external stakeholders
Preparing and presenting executive governance meetings
Basilea Pharmaceutica
International Clinical Trial Coordinator
06.2009 - 06.2010
Job overview
Provide support to the management of international phase III trials
Medius AG
Drug Regulatory Affairs Assistant
04.2009 - 06.2009
Job overview
Support DRA-Manager with submissions to regulatory authorities
Arpida
Junior Clinical Trial Manager
08.2008 - 02.2009
Job overview
Provide support to the Clinical Trial Manager in the management of Phase II and III outsourced studies (indication: skin-infections)
Memory Clinic
Study Nurse
01.2007 - 03.2008
Job overview
Company Overview: (University Hospital Basel)
Managing a study in Alzheimer's disease in collaboration with the investigator and sponsor
Data entry
Performing and assisting with patient assessments
Support monitoring activity
Apply to ICH-GCP
Direct contact with patients and relatives
(University Hospital Basel)
Midwife
08.1998 - 11.2006
Education
Donau Universität Krems
MSc from Clinical Research
06.2010
Hebammenakademie
Mistelbach, A
Midwife
01.1998
A - level
01.1995
Skills
G-suite tools and MS Office: Word, Excel, Powerpoint
Proficient user of AI tools
Relationship building
Goal setting
Process improvement
Visionary thinking
Strategic planning
Team building
Influencing others
Financial acumen
Motivating teams
Contract oversight
Team leadership
Risk assessment
Performance management
Conflict resolution
Cross-functional collaboration
KPI development
Project planning
Decision-making
Project management
Goal oriented
Negotiation
Contract management
Quality control
Excellent communication
Active listening
Reliability
Idea development and brainstorming
Data analysis
Further Professional Trainings
2025, Oxford Woman Leadership development programme
2022, Process Optimization and Quality Management AKAD online
2019, Effective Project Leadership and Communication Roche Training Center, Kaiseraugst
2018, The Importance of Delegating Roche Training Academy
04/01/17, 10/01/19, Matrix-Leader / 4 Module Roche Leadership Training
01/01/15, 06/01/16, Leadership Skills Training / Coaching Program Roche Basel Training Center
2013, Successful Presentations Roche Basel Training Center
2012, Successful Negotiation Roche Basel Training Center
2014, Study Management Team SMT in Action Roche Basel Training Center
2012, Project Management of Clinical Trials Roche Basel Training Center
Summary Of Competencies
In-depth knowledge and experience in management of clinical studies, in pharma and hospital environment (+15 years) throughout all phases of drug development (phase I - IV) in matrix environment and for all stages in small and large pharma companies
7 years experience in early phase drug development including Entry into Human studies and in different therapeutic areas: Immunology: IBD, Hep.B /Oncology: different cancer types
7 years experience in large late stage (phase III and IV) studies in leading large global study teams in collaboration with CRO's and other vendors
Solid vendor alliance / relations management experience for global CRO, central laboratories and mobile nursing vendors at Roche
Knowledge in vendor partnership management has been gained in day to day business activities for clinical trials and in total 3 years 'rotation' as a dedicated vendor and sourcing manager role within global environment
Experience in the set up of a fully outsourced working model with a CRO for early phase HV studies for Roche pRED (early phase study unit)
Chair of pan-Roche mobile nursing governance network (part time)
Member of pan-Roche CRO vendor governance network
Constant learning and improvement/ implementing innovative solutions
Consultancy and mentoring of team members
Outcome and solution oriented, self organized, agile, communicative, creative and innovative networker, leader and team player applying situational leadership
Clinical Study Specialist - Research/Study Nurse at Select Source International: Contractor position at Kimberly-Clark CorporationClinical Study Specialist - Research/Study Nurse at Select Source International: Contractor position at Kimberly-Clark Corporation
Clinical Research Assistant II /Research Study Coordinator at UT SouthwesternClinical Research Assistant II /Research Study Coordinator at UT Southwestern