- Performed and oversee submissions IRB/EC/CA and other EMEA regulatory bodies on behalf of Sponsors.
- Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements. Perform QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements.
- Perform submissions via EU portal (CTIS Part I and Part II) or other Regulatory Bodies on behalf of sponsors and in accordance with Clinical Trial Regulation 536/2014
- Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level (DE, ES and FR).
Site contracting study start-up phase, Onco studies.
- Developing study specific contracting and budgeting strategy with the internal stakeholders
- Primary contact and process owner for interactions between TC and Lilly US, Legal / Finance related to process changes, documentation requirements, and site contracting and budgeting issues.
- Development and realization of terms and provisions for country specific templates (implementation of EU 536/2014).
- Supporting, adapting and submission of relevant study documentation for CTIS submission (Part I and Part II) for DE and AT.
- Adaptation and revision of ICFs, SOPs and eTMF specifications to EU No. 536/2014.
- Contracting in compliance with planned enrolment timelines.
- Mentoring and Training of new hires.
Responsible for feasibility process,
Project Management and recruitment tasks of the clinical operations team.
Responsible for study budgets, negotiations and contracting, Quality Management.
Line management function for 4 team members.
Vendor Management, Local site management and coordinating of local sites.
- Set- up eTMF Database and Maintenance.
- Manage site ready documentation,
- Preparing Inspection readiness for the Covid-19 trials, Phase IIa,
- Prepare and Follow-up Audits, CAPA Plans.
- Manage Study Budget Plans ? Controlling and tracking,
Monitoring activities (Peru / Panama).
Managing all site-related contracting and budget tasks for all Clinical Operations Study Phases.
Tracking, global reporting and communication of all study issues.
Sole responsibility for Managing Non- Amgen Sponsored Clinical Trials (28 ISS projects with Sponsor organizations).
Implementation of national and international SOP?s; Budget and Fair Market Value Assessments; Financial project management.
Collaborating with EMEA and US HQ teams.
Supporting resolutions for sponsor contract issues and local vendor contracting.
Inspection preparation: Mock and HA Inspection:
General support of Inspection Manager, e.g. development of trackers and overview, meeting organization, collection of information, Share Point set -up. Interaction with Health Authorities.
Releasing of Standard Operating Procedures (SOP) and Global ? SOP?s.
Creating and set-up the internal approval process for SOP?s.
Clinical Trial Specialist, Clinical Operations, (Oncology Phase I and Phase III, Dermatology). Organizing sponsor meetings with CRO?s, Affiliates, Kick-off Meetings; Review and align with CTT members on the key milestones and target timelines. Subject matter expert for clinical program study budget, review and planning; Accruals bookings on a monthly basis; Set-up Headquarter TMF, maintenance as well as set-up new TMF structures for local study sites.
2010 - 2014 : Non-Interventional and PASS- Studies
Customer: Essex Pharma/ MSD Sharp & Dohme GmbH/ MERCK USA
Role: Clinical Trial Coordinator
Tasks:
Performing of phase II, phase III studies according ICH-GCP standard and global Merck SOPs.
Non-Interventional and PASS- Studies, Emphasis on Immunology , Oncology.
Working Experience: Contract and Budget Management, interact with external Vendors, CRO?s: Perform und compile all required documentation for local and international Audits (FDA Audits). log, track and file all study documentation in the Trial-Master-File (paper-based and electronically), Monitoring of NIS- Study Sites.
2010 - 2010: Clinical Research Projects in Dermatology and Orthopedics, Medical Device Companies
Role: Project Manager
Tasks:
Product life-cycle management including product launch for aesthetic- dermatology products.
Phase I-III studies: Metabolic Syndrome (3 sites/ 25 patients).
Pilot study on the efficacy of changes in passive strain on lumbar segments during sleep in chronic pain syndromes.
2008 - 2008: Clinical Research Projects in Dermatology and Orthopedics, Medical Device Companies
Role: Project Manager
Tasks:
Product life-cycle management including product launch for aesthetic- dermatology products.
Phase I-III studies: Metabolic Syndrome (3 sites/ 25 patients).
Pilot study on the efficacy of changes in passive strain on lumbar segments during sleep in chronic pain syndromes.
2002 ? 2007: Project Management
Role: Project-Manager
Customer: aesthetic Dermatology Storz Medical AG, Tägerwilen, Switzerland.
Tasks:
Project Management and set-up a new therapy concept: aesthetic dermatology for shock-wave devices:
Initiating and roll-out of the study concept
Definition and Selection of analysis and evaluation methods
Site Selection in cooperation with Health Care Professionals (HCP).
Documentation and writing of study reports on a regular basis.
1997 ? 2002: Managing
Role: Managing Director
Customer: RELUX lighting systems
1994 ? 1997: field of communications and international marketing activities
Global Marketing Manager
Dornier Medizintechnik GmbH, München ? Singapore Atlanta
Tasks:
Responsible for the field of communications and international marketing activities in the corporate group, various branches
1992 ? 1994: Key Account Management
Role: Sales- and Marketing Manager
Customer: EURODATA GmbH Berlin, Affiliate of Daimler-Benz AG
Tasks:
Sole responsibility for all fields of marketing, public relations and sales. Key Account Management in East-European Countries.
1991 ? 1992: Development of a Start-up business data security products
Customer: Fa. Comsecur IME AG, Basel/ Switzerland
1987 ? 1991: Spaceflight Earth exploration, meteorology
Role: Junior Manager
Customer: Dornier System GmbH, Friedrichshafen
2019-04
Clinical Study Lead:
Legal basics:
Contracting, insurances, budget and fee calculations, data protection.
Study management: Study infrastructure (premises, equipment, pharmacy, laboratory, archive); SOP, team building and motivation.
Special tasks of the principal investigator: Resource and cost planning; training, distribution of tasks; delegation list; recruitment and patient enrollment; patient safety; discontinuation criteria; adverse events; investigational medicinal products; labelling; proof of use; storage; study closure.
Quality assurance: Basics (CAPA); study monitoring: audits and inspections, protocol deviations
1984 ? 1987
Business-Management at the college of Villingen- Schwenningen
Focal point: International Marketing and Controlling.
Master: Differences between French and German financial Accounting under European legislation.
Degree: Master of Business Administration, MBA
1984 ? 1985
International practical training and work experience:
Located in Antwerp, Belgium
Flight assistant for DHL in Hong Kong, Macau, London, Brussels and New York
1981 - 1984
General qualifications for university entrance at the Commercial High School of Emmendingen.
Further Education
Company Controlling and Financing
Medical device consultant (§31 MPG),
IHK examination as trainer supervisor
All MS Office Applications,
Foreign Corrupt Act
Clinical Trial Administration
Clinical Trial Management
Good Clinical Practice, ICH- GCP
The Basics of Monitoring, Drug Accountability
Audit and Inspections of Clinical Trials of Drugs and Biologics
Intellectual Property Rights / Innovations on request
Publications on request
- Medical Device (Urology, Orthopaedics, Dermatology)
- Biotechnology (Oncology, Cardiovascular, Infectious Disease and Vaccines, Rare Diseases)
- Performed and oversee submissions IRB/EC/CA and other EMEA regulatory bodies on behalf of Sponsors.
- Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements. Perform QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements.
- Perform submissions via EU portal (CTIS Part I and Part II) or other Regulatory Bodies on behalf of sponsors and in accordance with Clinical Trial Regulation 536/2014
- Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level (DE, ES and FR).
Site contracting study start-up phase, Onco studies.
- Developing study specific contracting and budgeting strategy with the internal stakeholders
- Primary contact and process owner for interactions between TC and Lilly US, Legal / Finance related to process changes, documentation requirements, and site contracting and budgeting issues.
- Development and realization of terms and provisions for country specific templates (implementation of EU 536/2014).
- Supporting, adapting and submission of relevant study documentation for CTIS submission (Part I and Part II) for DE and AT.
- Adaptation and revision of ICFs, SOPs and eTMF specifications to EU No. 536/2014.
- Contracting in compliance with planned enrolment timelines.
- Mentoring and Training of new hires.
Responsible for feasibility process,
Project Management and recruitment tasks of the clinical operations team.
Responsible for study budgets, negotiations and contracting, Quality Management.
Line management function for 4 team members.
Vendor Management, Local site management and coordinating of local sites.
- Set- up eTMF Database and Maintenance.
- Manage site ready documentation,
- Preparing Inspection readiness for the Covid-19 trials, Phase IIa,
- Prepare and Follow-up Audits, CAPA Plans.
- Manage Study Budget Plans ? Controlling and tracking,
Monitoring activities (Peru / Panama).
Managing all site-related contracting and budget tasks for all Clinical Operations Study Phases.
Tracking, global reporting and communication of all study issues.
Sole responsibility for Managing Non- Amgen Sponsored Clinical Trials (28 ISS projects with Sponsor organizations).
Implementation of national and international SOP?s; Budget and Fair Market Value Assessments; Financial project management.
Collaborating with EMEA and US HQ teams.
Supporting resolutions for sponsor contract issues and local vendor contracting.
Inspection preparation: Mock and HA Inspection:
General support of Inspection Manager, e.g. development of trackers and overview, meeting organization, collection of information, Share Point set -up. Interaction with Health Authorities.
Releasing of Standard Operating Procedures (SOP) and Global ? SOP?s.
Creating and set-up the internal approval process for SOP?s.
Clinical Trial Specialist, Clinical Operations, (Oncology Phase I and Phase III, Dermatology). Organizing sponsor meetings with CRO?s, Affiliates, Kick-off Meetings; Review and align with CTT members on the key milestones and target timelines. Subject matter expert for clinical program study budget, review and planning; Accruals bookings on a monthly basis; Set-up Headquarter TMF, maintenance as well as set-up new TMF structures for local study sites.
2010 - 2014 : Non-Interventional and PASS- Studies
Customer: Essex Pharma/ MSD Sharp & Dohme GmbH/ MERCK USA
Role: Clinical Trial Coordinator
Tasks:
Performing of phase II, phase III studies according ICH-GCP standard and global Merck SOPs.
Non-Interventional and PASS- Studies, Emphasis on Immunology , Oncology.
Working Experience: Contract and Budget Management, interact with external Vendors, CRO?s: Perform und compile all required documentation for local and international Audits (FDA Audits). log, track and file all study documentation in the Trial-Master-File (paper-based and electronically), Monitoring of NIS- Study Sites.
2010 - 2010: Clinical Research Projects in Dermatology and Orthopedics, Medical Device Companies
Role: Project Manager
Tasks:
Product life-cycle management including product launch for aesthetic- dermatology products.
Phase I-III studies: Metabolic Syndrome (3 sites/ 25 patients).
Pilot study on the efficacy of changes in passive strain on lumbar segments during sleep in chronic pain syndromes.
2008 - 2008: Clinical Research Projects in Dermatology and Orthopedics, Medical Device Companies
Role: Project Manager
Tasks:
Product life-cycle management including product launch for aesthetic- dermatology products.
Phase I-III studies: Metabolic Syndrome (3 sites/ 25 patients).
Pilot study on the efficacy of changes in passive strain on lumbar segments during sleep in chronic pain syndromes.
2002 ? 2007: Project Management
Role: Project-Manager
Customer: aesthetic Dermatology Storz Medical AG, Tägerwilen, Switzerland.
Tasks:
Project Management and set-up a new therapy concept: aesthetic dermatology for shock-wave devices:
Initiating and roll-out of the study concept
Definition and Selection of analysis and evaluation methods
Site Selection in cooperation with Health Care Professionals (HCP).
Documentation and writing of study reports on a regular basis.
1997 ? 2002: Managing
Role: Managing Director
Customer: RELUX lighting systems
1994 ? 1997: field of communications and international marketing activities
Global Marketing Manager
Dornier Medizintechnik GmbH, München ? Singapore Atlanta
Tasks:
Responsible for the field of communications and international marketing activities in the corporate group, various branches
1992 ? 1994: Key Account Management
Role: Sales- and Marketing Manager
Customer: EURODATA GmbH Berlin, Affiliate of Daimler-Benz AG
Tasks:
Sole responsibility for all fields of marketing, public relations and sales. Key Account Management in East-European Countries.
1991 ? 1992: Development of a Start-up business data security products
Customer: Fa. Comsecur IME AG, Basel/ Switzerland
1987 ? 1991: Spaceflight Earth exploration, meteorology
Role: Junior Manager
Customer: Dornier System GmbH, Friedrichshafen
2019-04
Clinical Study Lead:
Legal basics:
Contracting, insurances, budget and fee calculations, data protection.
Study management: Study infrastructure (premises, equipment, pharmacy, laboratory, archive); SOP, team building and motivation.
Special tasks of the principal investigator: Resource and cost planning; training, distribution of tasks; delegation list; recruitment and patient enrollment; patient safety; discontinuation criteria; adverse events; investigational medicinal products; labelling; proof of use; storage; study closure.
Quality assurance: Basics (CAPA); study monitoring: audits and inspections, protocol deviations
1984 ? 1987
Business-Management at the college of Villingen- Schwenningen
Focal point: International Marketing and Controlling.
Master: Differences between French and German financial Accounting under European legislation.
Degree: Master of Business Administration, MBA
1984 ? 1985
International practical training and work experience:
Located in Antwerp, Belgium
Flight assistant for DHL in Hong Kong, Macau, London, Brussels and New York
1981 - 1984
General qualifications for university entrance at the Commercial High School of Emmendingen.
Further Education
Company Controlling and Financing
Medical device consultant (§31 MPG),
IHK examination as trainer supervisor
All MS Office Applications,
Foreign Corrupt Act
Clinical Trial Administration
Clinical Trial Management
Good Clinical Practice, ICH- GCP
The Basics of Monitoring, Drug Accountability
Audit and Inspections of Clinical Trials of Drugs and Biologics
Intellectual Property Rights / Innovations on request
Publications on request
- Medical Device (Urology, Orthopaedics, Dermatology)
- Biotechnology (Oncology, Cardiovascular, Infectious Disease and Vaccines, Rare Diseases)