Senior Clinical Research Consultant

10/2019 – 12/2020

Scope
• Responsible for assigned immonological project
- one phase 2 global in patients with LGI1 Autoimmune Encephalitis
Major Accountabilities
• Develop, maintain and execute the Clinical Development Plan (CDP) and the respective clinical trial for phase II together with Clinical Program Director and other members of the clinical sub-team
• Responsible for vendor selection (Master Service Agreement and work order negotiations, definition of scope of work, timelines, KPIs and milestone payments)

Successfully piloted new operational model for rare disease indication in patients with LGI1 Autoimmune Encephalitis.

Klinische Forschung, Gute Klinische Praxis, Projektleitung / Teamleitung (IT), Projekt-Dokumentation, Projekt-Qualitätssicherung

8/2018 – 12/2023

Configure and maintain vigilance system for medical devices, safety reporting, and exchange with competent authorities for interdisciplinary med-tech start-up offering sophisticated test that detects early symptoms of heart disease.

Projektleitung / Teamleitung, Projektmanagement

3/2017 – 12/2017

Identified sites for a clinical study of rare disease (PNPO Deficiency) in Germany and Switzerland. Supported expansion of study from US to Europe.

Klinische Forschung, Gute Klinische Praxis, Neurologie

3/2017 – 12/2017

• Identified sites for a clinical study of rare disease (PNPO Deficiency) in Germany and Switzerland. Supported expansion of study from US to Europe.

Klinische Forschung, Gute Klinische Praxis, Neurologie

3/2017 – offen

Launched privately funded multi-national organization linking European suppliers of top-quality medical devices, and nutritional supplements with healthcare providers in Western Africa.

Personalführung, Business Development, Produktmanagement

9/2016 – 6/2020

Scope
• Responsible for assigned projects in clinical nutrition including
- a program of 2 phase 3 trials in China in surgical patients
- a program of 4 FSMP trials in China in patients with Severe Acute Pancreatitis, esophageal and gastric cancer, stroke and patients with CKD
- one phase 1b study in patients with CKD
- one NIS in 7 Asian countries in patients after major elective surgery

Major Accountabilities
• Develop, maintain and execute the Clinical Development Plan (CDP) and the respective clinical trials for phase III and FSMP trials together with Clinical Program Director and other members of the clinical sub-team
• Responsible for vendor selection (Master Service Agreement and work order negotiations, definition of scope of work, timelines, KPIs and milestone payments)
• Enhanced efficiency of operations in China by establishing standard processes and procedures for research studies in enteral and parenteral nutrition business units. Devised clinical development plans and defined marketing strategy for several products on Chinese market.
• Restructured mission-critical study that was challenged by data quality and recruitment issues to ensure success of ten-year marketing plans for parenteral nutrition product in China. Obtained market authorization and generated sales.

Klinische Forschung, Gute Klinische Praxis, Ernährungswissenschaften, Mehrprojektmanagement, Projekt-Qualitätssicherung, Projektmanagement - Konzeption / Vorgehensmodell

8/2015 – 9/2016

Scope
• Responsible project manager lead for one global phase III study in Alzheimer`s Disease from planning to execution and reporting

Major Accountabilities
• Preparation of budget proposals and negotiation of contract terms and conditions with the sponsor
• Acting as primary contact for clients for all scientific and operational aspects during the course of the study
• Responsible lead for clinical project team to provide training, timelines and budgets

Klinische Forschung, Gute Klinische Praxis, Neurologie, Projekt-Qualitätssicherung, Projektmanagement

6/2011 – 12/2017

Launched privately funded Clinical Research Organization providing global QA and consultancy services to the pharmaceutical, biotechnology, medical device, and food industry.

Klinische Arbeiten, Klinische Forschung, Gute Klinische Praxis, Personalcontrolling, Geschäftsfeldstrategie

5/2010 – 9/2015

Scope
• Responsible for assigned neurological projects including
- a program of 2 global phase 3 trials in Epilepsy
- a program of 2 follow up trials (OLE & MAP) in Epilepsy
Major Accountabilities
• Develop, maintain and execute the Clinical Development Plan (CDP) and the respective clinical trials for phase III together with Clinical Program Director and other members of the clinical sub-team
• Responsible for vendor selection (Master Service Agreement and work order negotiations, definition of scope of work, timelines, KPIs and milestone payments)
• Team lead for Associate Clinical Project Managers

Klinische Forschung, Gute Klinische Praxis, Mehrprojektmanagement, Projektmanagement

5/2009 – 4/2010

Scope
• Responsible project manager lead for
- 1 international phase III trial in Pulmonary Atrial Hypertension (PAH)
- 1 international phase II trial in male contraception
- 1 international phase II trial in cardio-pulmonary bypass (CPB)
- 1 international phase III trial in coronary artery bypass graft (CABG) surgery
- 1 international phase II trial in Atrial Fibrillation (AF)
- 3 international phase III trial in clinical nutrition (infants, Low birth weight an very low birth weight children)

from planning to execution and reporting

Major Accountabilities
• Preparation of budget proposals and negotiation of contract terms and conditions with the sponsor
• Acting as primary contact for clients for all scientific and operational aspects during the course of the study
• Responsible lead for clinical project team to provide training, timelines and budgets
• QMR: Responsible for the set-up and maintenance of European QMS of GRS

I joined GRS during a period of organisational restructuring and built team of new recruits to successfully manage three international clinical trials. My team subsequently awarded further studies, including a major international anticoagulative study and three studies in clinical nutrition in premature infants.

Klinische Forschung, Gute Klinische Praxis, Qualitätsmanagement / QS / QA (IT), Mehrprojektmanagement, Projekt-Qualitätssicherung

11/2007 – 4/2009

For scope and main responsabilities see SPM and QMR position at GRS

Mehrprojektmanagement

7/2007 – 11/2007

For scope and main responsabilities see SPM and QMR position at GRS

Klinische Forschung, Gute Klinische Praxis, Mehrprojektmanagement

6/2003 – 6/2007

Scope
• Responsible for assigned projects including
- a program of 7 phase IV trials in Epilepsy
- a program of 1 phase IV trails in Migraine prophylaxis
- a program of 3 phase IV trials in Alzheimer`s Disease
- a program of 1 phase IV trail in contraception
- a program of 3 phase IV trials in Schizophrenia
- a program of 1 phase IV trails in Migraine prophylaxis
- a program of 2 phase IV and 3 phase 2/3 trials in Multiple Myeloma
- a program of 5 phase IV trails in CKD (Anaemia)

Major Accountabilities
• Maintain and execute the Clinical Development Plan (CDP) and the respective clinical trials for phase III together with Clinical Program Director and other members of the clinical sub-team
• Responsible for vendor selection (Master Service Agreement and work order negotiations, definition of scope of work, timelines, KPIs and milestone payments)
• Team lead for Clinical Research Associates

Successfully set-up, piloted and established new operational model for Non-interventional trials in various indications

Klinische Forschung, Gute Klinische Praxis, Projektmanagement

9/2002 – 5/2003

Scope
• Responsible Site Manager for phase III-IV trials in patients with Osteo- and rheumatoid arthritis, post-operative pain (Gon- and Coxarthrosis), Malignant pain (Mamma Carcinoma), and Neuropathic pain
• Responsible for SQVs, SIVs, IMVs, and COVs

Klinische Arbeiten, Klinische Forschung, Gute Klinische Praxis, Projekt-Qualitätssicherung