Clinical Operation/Study/Trial Management, Lecture (Pharma)
Aktualisiert am 02.04.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 02.04.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Project management
Good Recruitment Practice
Social Media campaign
Site selection
vendor selection/management

Einsatzorte

Einsatzorte

Bonn (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

11 Monate
2023-05 - heute

Projectmanagement

Assistant Professor for Clinical Research Associates, Project Managers, Study Nurses/coordinators, Lecturer
Assistant Professor for Clinical Research Associates, Project Managers, Study Nurses/coordinators, Lecturer
GCP Pharmaakademie Leipzig, Germany
6 Monate
2023-07 - 2023-12

Therapeutic area ?Celiac Disease/Gastrology?

Project Manager Clinical Research
Project Manager Clinical Research
  • Trial Management (start up phase), budget, contracts (vendors, labs, etc.)
  • CRO Oversight
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • Team Meetings
  • CTIS/non-CTIS Regulatory Submissions and discussion
DR. FALK PHARMA GMBH, Freiburg, Germany, Phase II
1 Jahr 4 Monate
2022-09 - 2023-12

Therapeutic area ?Anaesthetic?

Clinical Operations Manager
Clinical Operations Manager
  • Trial Management (start up, conduct, close), budget, contracts (vendors, labs, etc.)
  • CRO Oversight
  • safety reporting,
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • TMF, Training, Team Meetings, etc.
  • Regulatory Submissions and discussion
PAION Deutschland GmbH, Aachen, Germany, Phase I
5 Monate
2022-03 - 2022-07

Therapeutic area ?Oncology?

Clinical Trial Manager
Clinical Trial Manager
  • Trial Management (start up, conduct, close), budget, contracts (sites, local vendors, etc.)
  • CRO Oversight
  • Feasibilities, site selection,
  • safety reporting,
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • TMF, Training, Team Meetings, etc.
  • Investigator Meetings
  • Regulatory Submissions and discussion
CatalYm GmbH/ München/ Germany/ Phase I/II
1 Jahr 6 Monate
2020-09 - 2022-02

Therapeutic area ?Oncology ? Breast Cancer?

Local Study Associate Director
Local Study Associate Director
  • Trial Management (start up, conduct, close), budget, contracts (sites, local vendors, etc.)
  • Feasibilities (KEE (high level), Country, Site), site selection,
  • resource/FTE planning,
  • safety reporting,
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • TMF, Training, Team Meetings, etc.
  • Investigator Meetings
  • Regulatory Submissions and discussion
auf Anfrage
11 Monate
2019-10 - 2020-08

Therapeutic area ?CNS/Cardiology?

Local Trial Manager
Local Trial Manager
  • Trial Management (start up, conduct, close), budget
  • Review & finalization of study documents (protocol, riskmonitoring plans, study manuals, CRFs, etc.),
  • Feasibilities (Site),
  • resource/FTE planning,
  • safety reporting,
  • contracts (Vendors, Sites, etc.)
  • ensure that ICH/GCP & SOPs will be fulfilled, site selection, TMF, Training, Meetings, etc.
Janssen-Cilag GmbH
Neuss/ Germany
9 Monate
2019-01 - 2019-09

Therapeutic area ?Oncology/Breast Cancer?

Head of Clinical Operations
Head of Clinical Operations
  • Provides direction and leadership to the clinical operations department and staff,
  • coordination of daily business processes,
  • overview project/data management and monitoring
  • human resources management, FTE calculation and appraisals in cooperation with the CEO
WSG Westdeutsche Studiengruppe, Mönchengladbach, Germany
6 Monate
2018-05 - 2018-10

Therapeutic area ?Immunology, Hepatology and Dermatology?

Global Trial Operations Manager
Global Trial Operations Manager
  • Provides direction and leadership to country clinical operations teams (interface between countries and global study teams),
  • act as core study team member,
  • cooperate with regional operations managers (ROMs),
  • development and management of study timelines (Start-up, Data Base locks, Close-out), resources, risk and quality plans,
  • provides clinical operations expertise to ensure operational feasibility and delivery,
  • delivers operational elements of the study plan & monitoring plan
Novartis International AG
Basel, Switzerland
9 Monate
2017-06 - 2018-02

Therapeutic area ?Respiratory, Gastroenterology and Infectious Diseases?

International Clinical Trial Manager, Leader Study Management Team
International Clinical Trial Manager, Leader Study Management Team
  • Provides direction and leadership to one or more clinical operations teams,
  • development and management of the study timelines, resources, budget, risk and quality plans,
  • Provides clinical operations expertise to ensure operational feasibility and delivery,
  • Oversees forecasting of clinical/non-clinical supplies,
  • Delivers the operational elements of the study plan,
  • Day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work,
  • Identifies areas of best practice and process improvements,
  • Ensures study adherence to ICH/GCP and SOPs & Compliance
F. Hoffmann-La Roche Ltd
Basel/ Switzerland
1 Jahr 8 Monate
2015-09 - 2017-04

Therapeutic area ?Specialty Care?/ Multiple Sclerosis

Country Study Manager
Country Study Manager
  • Trial Management (start up, conduct, close), budget (5 Mio. Euro),
  • Review & finalization of study documents (protocol, riskmonitoring plans, study manuals, CRFs, etc.),
  • Feasibilities (Country, Protocol, Site),
  • resource/FTE planning,
  • safety reporting,
  • contracts (Vendors, Sites, etc.)
  • ensure that ICH/GCP & SOPs will be fulfilled, site selection, TMF, Training, Meetings, etc.
Roche Pharma AG
Grenzach/ Germany
2 Jahre 3 Monate
2012-09 - 2014-11

Therapeutic area ?Urea Cycle Disorder"

Lead Clinical Operations Northern America
Lead Clinical Operations Northern America
  • Development, review & finalization of study documents (protocol, data analysis plans, risk-monitoring plans, study manuals, CRFs, CSRs, etc.), Management of timelines (start up, conduct, close),
  • budget (~10 Mio. Euro), resources, medical & scientific, supply,
  • safety reporting,
  • vendors management (CRO, IVRS, central lab, courier, central locker, etc.),
  • contracts,
  • ensure that ICH/GCP & SOPs will be fulfilled, TMF, etc
Cytonet GmbH Co & KG
Weinheim/ Germany
1 Jahr 5 Monate
2011-03 - 2012-07

Therapeutic area ?Vaccines?

Global Study Team Leader
Global Study Team Leader
  • Leadership for 3 global study teams (Data Management, Regulatory Affairs, MedWriting, Biostatistic, Supply, Pharmacovigilance, Therapeutic experts),
  • Management of timelines (start up, conduct, close),
  • budget (~ 20 Mio. Euro),
  • resources/FTE planning, medical & scientific aspects, supply,
  • safety reporting,
  • vendors management (CRO, IVRS, central lab, courier, central locker, etc.), contracts,
  • ensure that ICH/GCP & SOPs will be fulfilled, site selection, eTMF
Baxter Innovations GmbH
Vienna/ Austria
10 Monate
2010-06 - 2011-03

Therapeutic area ?Pain?

Clinical Study Manager
Clinical Study Manager
  • Country management of timelines (start up, conduct, close),
  • budget, resources, quality & risk, supply,
  • safety reporting,
  • vendors management (lab, courier, locker, etc.), contracts,
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • site feasibility & selection,
  • training of CRA & CTAs,
  • EC/HA submissions & requests, preparation of country study documents,
  • TMF
Grünenthal GmbH
Aachen/ Germany
10 Monate
2009-08 - 2010-05

Therapeutic area ?Endothelin-Rezeptor-Antagonisten?/ Global Operations

Clinical Trial Operations Manager
Clinical Trial Operations Manager
  • Study management of timelines (start up, conduct, close), budget, resources, quality & risk, supply,
  • safety reporting,
  • vendor mamagement (CRO, IVRS, central lab, courier, central locker, etc.), contracts,
  • development, review & finalization of study documents (protocol, data analysis plans, risk-monitoring plans, study manuals, CRFs, etc.),
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • site selection, coordinating of EC/HA requests,
  • Co-Monitoring, motivation/clarification site visits,
  • TMF,
  • Investigator Meetings
Actelion Pharmaceuticals Ltd.
Basel/ Switzerland

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2023-11 - 2023-11

?ICH E8 (R1) & Patient Centricity?

DGPharMed, virtuell
DGPharMed, virtuell
1 Monat
2022-12 - 2022-12

?Harnessing Risk-Based Quality Management and Deep Learning to Improve Trial Knowledge and Drive Better Decision-Making and Outcomes?

Webinar, CluePoints, UK
Webinar, CluePoints, UK
1 Monat
2022-11 - 2022-11

?Pharmakovigilanz ? was reden die da?

DGPharMed, virtuell
DGPharMed, virtuell
1 Monat
2022-10 - 2022-10

GCP-Refresher ?ICH-GCP-konforme Durchführung klinischer Studien (online)

SMATOS GmbH & Co KG, Trier, Germany
SMATOS GmbH & Co KG, Trier, Germany
1 Monat
2022-03 - 2022-03

12th Operational Excellence in Clinical Trials Summit (OECT)

Berlin/ KP Morgan
Berlin/ KP Morgan
3 Monate
2021-02 - 2021-04

?Überblick und aktueller Stand zur ?MDR? ? Verordnung (EU) 2017/745?,Modul 1-3,

Technischen Hochschule Lübeck, DGPharMed, virtuell
Technischen Hochschule Lübeck, DGPharMed, virtuell
1 Monat
2019-07 - 2019-07

Soft-Skill-Seminar, GCP-Refresher-Seminar, ICH-E6(R2)

Mönchengladbach
Mönchengladbach
1 Monat
2018-02 - 2018-02

Medical Science Liaison (MSL) Training, ?From Science to Pharma?

Pty Ltd.
Pty Ltd.
1 Monat
2018-02 - 2018-02

?Statistische Aspekte in klinischen Studien?

DGPharMed, Neuss
DGPharMed, Neuss
1 Monat
2017-11 - 2017-11

TransCelerate Clinical Research Awareness, Access & Information Exchange webinar

TransCelerate BioPharma Inc., US
TransCelerate BioPharma Inc., US
1 Monat
2017-06 - 2017-06

?Datenschutz - Datentransfers ins Nicht EU/EWR Ausland?

DGPharMed, Mannheim
DGPharMed, Mannheim
1 Monat
2017-06 - 2017-06

?10 Ways To Revamp Your TMF QC Process"

LMK Clinical Research Consulting, Trial Master File Consulting & Services, Huntersville
LMK Clinical Research Consulting, Trial Master File Consulting & Services, Huntersville
1 Monat
2016-11 - 2016-11

?ICH-E6(R2) und neue MEDDEV ? Leitlinie. Quo vadis, Klinische Prüfung??

DGPharMed, Mannheim
DGPharMed, Mannheim
1 Monat
2016-06 - 2016-06

?Good Clinical Practice Training?

The Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK
The Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK
1 Monat
2014-11 - 2014-11

?Risk-based Monitoring - Trend, Hype oder wahre Innovation??

DGPharMed, Mannheim
DGPharMed, Mannheim
1 Monat
2014-05 - 2014-05

Nicht-klinische Entwicklung unterschiedlicher Produktklassen?

MC Toxicology Consulting GmbH, Wien
MC Toxicology Consulting GmbH, Wien
1 Monat
2014-04 - 2014-04

?Verträge für die klinische Forschung?

DGPharMed, Mannheim
DGPharMed, Mannheim
10 Jahre 1 Monat
1987-10 - 1997-10

Study of Chemistry

Master of Science, Rheinische Friedrich-Wilhelm-Universität, Bonn, Germany
Master of Science
Rheinische Friedrich-Wilhelm-Universität, Bonn, Germany
1 Monat
1987-06 - 1987-06

Schüler

High school graduate (Allgemeine Hochschulreife), St. Michael Gymnasium Bad Münstereifel, Germany
High school graduate (Allgemeine Hochschulreife)
St. Michael Gymnasium Bad Münstereifel, Germany

Kompetenzen

Kompetenzen

Top-Skills

Project management Good Recruitment Practice Social Media campaign Site selection vendor selection/management

Produkte / Standards / Erfahrungen / Methoden

SPECIAL QUALIFICATIONS DURING STUDY

1992-1997 

Managing Director & Owner Fun & Sailing (travel agency), Bonn,

specialized group travel for sailing and skiing


1986-1996

Temporary assistant at the hospitals ?Kreiskrankenhaus Mechernich? and ?Universitätsklinikum Bonn? in the areas of surgery, urology,

internal and intensive care medicine


1993-1995 

Lecturer for chemistry and physics in medicine at the nurses clinic school ?Kreiskrankenhaus Mechernich?, Germany


PERSONAL SKILLS

Regarding clinical business:

  • over 20 years of experience managing scientific aspects and operational tasks in a multidisciplinary organization
  • ability to manage projects with multiple parallel activities and leading global trial teams and cross functional project teams
  • knowledge of drug development process in early and full development
  • results-driven self-starter and decision taker; open, confident and persuasive, succeeding through influence
  • creative and innovative approach with a sharp and objective intellect, experienced in balancing big picture thinking with detailed analysis
  • strong cooperative team player, ability to be flexible and adapt to a changing environment
  • used to helping a business achieve its objectives
  • well developed interpersonal skills with good presence; experienced presenter & communicator
  • good planning, prioritization, problem solving and organizational skills
  • resilient, energetic and enthusiastic; responding constructively to challenging new ideas and inputs & motivation of colleges


KEYNOTE SPEAKER

11/2023

9th annual CMPRR Summit - Monitoring and Patient Recruitment

Retention on 15th & 16th November 2023 in Barcelona, Spain


03/2023

12th Operational Excellence in Clinical Trials Summit (OECT)/ Berlin/ ?Sponsor of choice


04/2018

9 th Clinical Trials Innovation Programme (CTIP)/ Frankfurt/ ?Real World Data ? The New Upcoming Data Source in Clinical trials?

Einsatzorte

Einsatzorte

Bonn (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

11 Monate
2023-05 - heute

Projectmanagement

Assistant Professor for Clinical Research Associates, Project Managers, Study Nurses/coordinators, Lecturer
Assistant Professor for Clinical Research Associates, Project Managers, Study Nurses/coordinators, Lecturer
GCP Pharmaakademie Leipzig, Germany
6 Monate
2023-07 - 2023-12

Therapeutic area ?Celiac Disease/Gastrology?

Project Manager Clinical Research
Project Manager Clinical Research
  • Trial Management (start up phase), budget, contracts (vendors, labs, etc.)
  • CRO Oversight
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • Team Meetings
  • CTIS/non-CTIS Regulatory Submissions and discussion
DR. FALK PHARMA GMBH, Freiburg, Germany, Phase II
1 Jahr 4 Monate
2022-09 - 2023-12

Therapeutic area ?Anaesthetic?

Clinical Operations Manager
Clinical Operations Manager
  • Trial Management (start up, conduct, close), budget, contracts (vendors, labs, etc.)
  • CRO Oversight
  • safety reporting,
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • TMF, Training, Team Meetings, etc.
  • Regulatory Submissions and discussion
PAION Deutschland GmbH, Aachen, Germany, Phase I
5 Monate
2022-03 - 2022-07

Therapeutic area ?Oncology?

Clinical Trial Manager
Clinical Trial Manager
  • Trial Management (start up, conduct, close), budget, contracts (sites, local vendors, etc.)
  • CRO Oversight
  • Feasibilities, site selection,
  • safety reporting,
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • TMF, Training, Team Meetings, etc.
  • Investigator Meetings
  • Regulatory Submissions and discussion
CatalYm GmbH/ München/ Germany/ Phase I/II
1 Jahr 6 Monate
2020-09 - 2022-02

Therapeutic area ?Oncology ? Breast Cancer?

Local Study Associate Director
Local Study Associate Director
  • Trial Management (start up, conduct, close), budget, contracts (sites, local vendors, etc.)
  • Feasibilities (KEE (high level), Country, Site), site selection,
  • resource/FTE planning,
  • safety reporting,
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • TMF, Training, Team Meetings, etc.
  • Investigator Meetings
  • Regulatory Submissions and discussion
auf Anfrage
11 Monate
2019-10 - 2020-08

Therapeutic area ?CNS/Cardiology?

Local Trial Manager
Local Trial Manager
  • Trial Management (start up, conduct, close), budget
  • Review & finalization of study documents (protocol, riskmonitoring plans, study manuals, CRFs, etc.),
  • Feasibilities (Site),
  • resource/FTE planning,
  • safety reporting,
  • contracts (Vendors, Sites, etc.)
  • ensure that ICH/GCP & SOPs will be fulfilled, site selection, TMF, Training, Meetings, etc.
Janssen-Cilag GmbH
Neuss/ Germany
9 Monate
2019-01 - 2019-09

Therapeutic area ?Oncology/Breast Cancer?

Head of Clinical Operations
Head of Clinical Operations
  • Provides direction and leadership to the clinical operations department and staff,
  • coordination of daily business processes,
  • overview project/data management and monitoring
  • human resources management, FTE calculation and appraisals in cooperation with the CEO
WSG Westdeutsche Studiengruppe, Mönchengladbach, Germany
6 Monate
2018-05 - 2018-10

Therapeutic area ?Immunology, Hepatology and Dermatology?

Global Trial Operations Manager
Global Trial Operations Manager
  • Provides direction and leadership to country clinical operations teams (interface between countries and global study teams),
  • act as core study team member,
  • cooperate with regional operations managers (ROMs),
  • development and management of study timelines (Start-up, Data Base locks, Close-out), resources, risk and quality plans,
  • provides clinical operations expertise to ensure operational feasibility and delivery,
  • delivers operational elements of the study plan & monitoring plan
Novartis International AG
Basel, Switzerland
9 Monate
2017-06 - 2018-02

Therapeutic area ?Respiratory, Gastroenterology and Infectious Diseases?

International Clinical Trial Manager, Leader Study Management Team
International Clinical Trial Manager, Leader Study Management Team
  • Provides direction and leadership to one or more clinical operations teams,
  • development and management of the study timelines, resources, budget, risk and quality plans,
  • Provides clinical operations expertise to ensure operational feasibility and delivery,
  • Oversees forecasting of clinical/non-clinical supplies,
  • Delivers the operational elements of the study plan,
  • Day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work,
  • Identifies areas of best practice and process improvements,
  • Ensures study adherence to ICH/GCP and SOPs & Compliance
F. Hoffmann-La Roche Ltd
Basel/ Switzerland
1 Jahr 8 Monate
2015-09 - 2017-04

Therapeutic area ?Specialty Care?/ Multiple Sclerosis

Country Study Manager
Country Study Manager
  • Trial Management (start up, conduct, close), budget (5 Mio. Euro),
  • Review & finalization of study documents (protocol, riskmonitoring plans, study manuals, CRFs, etc.),
  • Feasibilities (Country, Protocol, Site),
  • resource/FTE planning,
  • safety reporting,
  • contracts (Vendors, Sites, etc.)
  • ensure that ICH/GCP & SOPs will be fulfilled, site selection, TMF, Training, Meetings, etc.
Roche Pharma AG
Grenzach/ Germany
2 Jahre 3 Monate
2012-09 - 2014-11

Therapeutic area ?Urea Cycle Disorder"

Lead Clinical Operations Northern America
Lead Clinical Operations Northern America
  • Development, review & finalization of study documents (protocol, data analysis plans, risk-monitoring plans, study manuals, CRFs, CSRs, etc.), Management of timelines (start up, conduct, close),
  • budget (~10 Mio. Euro), resources, medical & scientific, supply,
  • safety reporting,
  • vendors management (CRO, IVRS, central lab, courier, central locker, etc.),
  • contracts,
  • ensure that ICH/GCP & SOPs will be fulfilled, TMF, etc
Cytonet GmbH Co & KG
Weinheim/ Germany
1 Jahr 5 Monate
2011-03 - 2012-07

Therapeutic area ?Vaccines?

Global Study Team Leader
Global Study Team Leader
  • Leadership for 3 global study teams (Data Management, Regulatory Affairs, MedWriting, Biostatistic, Supply, Pharmacovigilance, Therapeutic experts),
  • Management of timelines (start up, conduct, close),
  • budget (~ 20 Mio. Euro),
  • resources/FTE planning, medical & scientific aspects, supply,
  • safety reporting,
  • vendors management (CRO, IVRS, central lab, courier, central locker, etc.), contracts,
  • ensure that ICH/GCP & SOPs will be fulfilled, site selection, eTMF
Baxter Innovations GmbH
Vienna/ Austria
10 Monate
2010-06 - 2011-03

Therapeutic area ?Pain?

Clinical Study Manager
Clinical Study Manager
  • Country management of timelines (start up, conduct, close),
  • budget, resources, quality & risk, supply,
  • safety reporting,
  • vendors management (lab, courier, locker, etc.), contracts,
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • site feasibility & selection,
  • training of CRA & CTAs,
  • EC/HA submissions & requests, preparation of country study documents,
  • TMF
Grünenthal GmbH
Aachen/ Germany
10 Monate
2009-08 - 2010-05

Therapeutic area ?Endothelin-Rezeptor-Antagonisten?/ Global Operations

Clinical Trial Operations Manager
Clinical Trial Operations Manager
  • Study management of timelines (start up, conduct, close), budget, resources, quality & risk, supply,
  • safety reporting,
  • vendor mamagement (CRO, IVRS, central lab, courier, central locker, etc.), contracts,
  • development, review & finalization of study documents (protocol, data analysis plans, risk-monitoring plans, study manuals, CRFs, etc.),
  • ensure that ICH/GCP & SOPs will be fulfilled,
  • site selection, coordinating of EC/HA requests,
  • Co-Monitoring, motivation/clarification site visits,
  • TMF,
  • Investigator Meetings
Actelion Pharmaceuticals Ltd.
Basel/ Switzerland

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2023-11 - 2023-11

?ICH E8 (R1) & Patient Centricity?

DGPharMed, virtuell
DGPharMed, virtuell
1 Monat
2022-12 - 2022-12

?Harnessing Risk-Based Quality Management and Deep Learning to Improve Trial Knowledge and Drive Better Decision-Making and Outcomes?

Webinar, CluePoints, UK
Webinar, CluePoints, UK
1 Monat
2022-11 - 2022-11

?Pharmakovigilanz ? was reden die da?

DGPharMed, virtuell
DGPharMed, virtuell
1 Monat
2022-10 - 2022-10

GCP-Refresher ?ICH-GCP-konforme Durchführung klinischer Studien (online)

SMATOS GmbH & Co KG, Trier, Germany
SMATOS GmbH & Co KG, Trier, Germany
1 Monat
2022-03 - 2022-03

12th Operational Excellence in Clinical Trials Summit (OECT)

Berlin/ KP Morgan
Berlin/ KP Morgan
3 Monate
2021-02 - 2021-04

?Überblick und aktueller Stand zur ?MDR? ? Verordnung (EU) 2017/745?,Modul 1-3,

Technischen Hochschule Lübeck, DGPharMed, virtuell
Technischen Hochschule Lübeck, DGPharMed, virtuell
1 Monat
2019-07 - 2019-07

Soft-Skill-Seminar, GCP-Refresher-Seminar, ICH-E6(R2)

Mönchengladbach
Mönchengladbach
1 Monat
2018-02 - 2018-02

Medical Science Liaison (MSL) Training, ?From Science to Pharma?

Pty Ltd.
Pty Ltd.
1 Monat
2018-02 - 2018-02

?Statistische Aspekte in klinischen Studien?

DGPharMed, Neuss
DGPharMed, Neuss
1 Monat
2017-11 - 2017-11

TransCelerate Clinical Research Awareness, Access & Information Exchange webinar

TransCelerate BioPharma Inc., US
TransCelerate BioPharma Inc., US
1 Monat
2017-06 - 2017-06

?Datenschutz - Datentransfers ins Nicht EU/EWR Ausland?

DGPharMed, Mannheim
DGPharMed, Mannheim
1 Monat
2017-06 - 2017-06

?10 Ways To Revamp Your TMF QC Process"

LMK Clinical Research Consulting, Trial Master File Consulting & Services, Huntersville
LMK Clinical Research Consulting, Trial Master File Consulting & Services, Huntersville
1 Monat
2016-11 - 2016-11

?ICH-E6(R2) und neue MEDDEV ? Leitlinie. Quo vadis, Klinische Prüfung??

DGPharMed, Mannheim
DGPharMed, Mannheim
1 Monat
2016-06 - 2016-06

?Good Clinical Practice Training?

The Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK
The Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK
1 Monat
2014-11 - 2014-11

?Risk-based Monitoring - Trend, Hype oder wahre Innovation??

DGPharMed, Mannheim
DGPharMed, Mannheim
1 Monat
2014-05 - 2014-05

Nicht-klinische Entwicklung unterschiedlicher Produktklassen?

MC Toxicology Consulting GmbH, Wien
MC Toxicology Consulting GmbH, Wien
1 Monat
2014-04 - 2014-04

?Verträge für die klinische Forschung?

DGPharMed, Mannheim
DGPharMed, Mannheim
10 Jahre 1 Monat
1987-10 - 1997-10

Study of Chemistry

Master of Science, Rheinische Friedrich-Wilhelm-Universität, Bonn, Germany
Master of Science
Rheinische Friedrich-Wilhelm-Universität, Bonn, Germany
1 Monat
1987-06 - 1987-06

Schüler

High school graduate (Allgemeine Hochschulreife), St. Michael Gymnasium Bad Münstereifel, Germany
High school graduate (Allgemeine Hochschulreife)
St. Michael Gymnasium Bad Münstereifel, Germany

Kompetenzen

Kompetenzen

Top-Skills

Project management Good Recruitment Practice Social Media campaign Site selection vendor selection/management

Produkte / Standards / Erfahrungen / Methoden

SPECIAL QUALIFICATIONS DURING STUDY

1992-1997 

Managing Director & Owner Fun & Sailing (travel agency), Bonn,

specialized group travel for sailing and skiing


1986-1996

Temporary assistant at the hospitals ?Kreiskrankenhaus Mechernich? and ?Universitätsklinikum Bonn? in the areas of surgery, urology,

internal and intensive care medicine


1993-1995 

Lecturer for chemistry and physics in medicine at the nurses clinic school ?Kreiskrankenhaus Mechernich?, Germany


PERSONAL SKILLS

Regarding clinical business:

  • over 20 years of experience managing scientific aspects and operational tasks in a multidisciplinary organization
  • ability to manage projects with multiple parallel activities and leading global trial teams and cross functional project teams
  • knowledge of drug development process in early and full development
  • results-driven self-starter and decision taker; open, confident and persuasive, succeeding through influence
  • creative and innovative approach with a sharp and objective intellect, experienced in balancing big picture thinking with detailed analysis
  • strong cooperative team player, ability to be flexible and adapt to a changing environment
  • used to helping a business achieve its objectives
  • well developed interpersonal skills with good presence; experienced presenter & communicator
  • good planning, prioritization, problem solving and organizational skills
  • resilient, energetic and enthusiastic; responding constructively to challenging new ideas and inputs & motivation of colleges


KEYNOTE SPEAKER

11/2023

9th annual CMPRR Summit - Monitoring and Patient Recruitment

Retention on 15th & 16th November 2023 in Barcelona, Spain


03/2023

12th Operational Excellence in Clinical Trials Summit (OECT)/ Berlin/ ?Sponsor of choice


04/2018

9 th Clinical Trials Innovation Programme (CTIP)/ Frankfurt/ ?Real World Data ? The New Upcoming Data Source in Clinical trials?

Vertrauen Sie auf GULP

Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

Fragen?

Rufen Sie uns an +49 89 500316-300 oder schreiben Sie uns:

Das GULP Freelancer-Portal

Direktester geht's nicht! Ganz einfach Freelancer finden und direkt Kontakt aufnehmen.