Senior Clinical Research Consultant

freiberufler Senior Clinical Research Consultant auf freelance.de
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53797 Lohmar, Rheinland
09.01.2021

Kurzvorstellung

18 years experience in the pharmaceutical/biotech industry and CRO in clinical drug development in a broad range of indications/therapeutic areas. Expertise in strategic planning of global drug development programs and operational execution.

Auszug Referenzen (1)

"During the few years I worked with J., I found him to be a highly organised individual with a keen eye for problem solving and proactiveness."
Managing Director
Kundenname anonymisiert
Tätigkeitszeitraum

6/2011 – 12/2017

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Monitor (CRA), Klinische Studie, Good clinical practice (GCP), Personalcontrolling, Geschäftsfeldstrategie

Ich biete

  • Business Development
  • Compliance management
  • Good clinical practice (GCP)
  • Klinische Monitor (CRA)
  • Klinische Studie
  • Medizinforschung
  • Personalführung
  • Pharmaforschung
  • Produktmanagement
  • Projekt-Qualitätssicherung
  • Projektleitung / Teamleitung
  • Projektmanagement
  • Six sigma

Projekt‐ & Berufserfahrung

Senior Clinical Project Manager
UCB Biosiences GmbH, Monheim
10/2019 – 12/2020 (1 Jahr, 3 Monate)
Pharmaindustrie
Tätigkeitszeitraum

10/2019 – 12/2020

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Projektleitung / Teamleitung (IT), Projekt-Dokumentation, Projekt-Qualitätssicherung


Global Medical Device Safety Officer
Cardisio GmbH, Frankfurt a,M,
8/2018 – offen (2 Jahre, 6 Monate)
Life Sciences
Tätigkeitszeitraum

8/2018 – offen

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

Projektleitung / Teamleitung, Projektmanagement


Clinical Research Consultant
Clinical Research Solutions Inc., Lohmar
3/2017 – 12/2017 (10 Monate)
Life Sciences
Tätigkeitszeitraum

3/2017 – 12/2017

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Neurologie


Clinical Research Consultant
GVI Clinical Research Solutions Inc., Lohmar
3/2017 – 12/2017 (10 Monate)
Life Sciences
Tätigkeitszeitraum

3/2017 – 12/2017

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Neurologie


Managing Director
ClinTAG Services GmbH, Lohmar
3/2017 – offen (3 Jahre, 11 Monate)
Gesundheitswesen
Tätigkeitszeitraum

3/2017 – offen

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Personalführung, Business Development, Produktmanagement


Senior Clinical Project Manager
Fresenius Kabi Deutschland GmbH, Bad Homburg
9/2016 – 6/2020 (3 Jahre, 10 Monate)
Life Sciences
Tätigkeitszeitraum

9/2016 – 6/2020

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Ernährungswissenschaft, Mehrprojektmanagement, Projekt-Qualitätssicherung, Projektmanagement - Konzeption / Vorgehensmodell


Senior Clinical Project Manager
Worldwide Clinical Trials, Berlin
8/2015 – 9/2016 (1 Jahr, 2 Monate)
Life Sciences
Tätigkeitszeitraum

8/2015 – 9/2016

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Neurologie, Projekt-Qualitätssicherung, Projektmanagement


Managing Director
ALLY Clinical Research Services GbR, Monheim
6/2011 – 12/2017 (6 Jahre, 7 Monate)
Life Sciences
Tätigkeitszeitraum

6/2011 – 12/2017

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Monitor (CRA), Klinische Studie, Good clinical practice (GCP), Personalcontrolling, Geschäftsfeldstrategie


Clinical Project Manager
UCB Biosiences GmbH, Monheim
5/2010 – 9/2015 (5 Jahre, 5 Monate)
Life Sciences
Tätigkeitszeitraum

5/2010 – 9/2015

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Mehrprojektmanagement, Projektmanagement


Senior Project Manager and Quality Management Representative (Festanstellung)
Global Research Services GmbH, Langenfeld
5/2009 – 4/2010 (1 Jahr)
Life Sciences
Tätigkeitszeitraum

5/2009 – 4/2010

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Qualitätsmanagement / QS / QA (IT), Mehrprojektmanagement, Projekt-Qualitätssicherung


Clinical Project Manager (Festanstellung)
Global Research Services GmbH, Langenfeld
11/2007 – 4/2009 (1 Jahr, 6 Monate)
Life Sciences
Tätigkeitszeitraum

11/2007 – 4/2009

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Mehrprojektmanagement


Associate Project Manager (Festanstellung)
Global Research Services GmbH, Langenfeld
7/2007 – 11/2007 (5 Monate)
CRO
Tätigkeitszeitraum

7/2007 – 11/2007

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Mehrprojektmanagement


Clinical Trial Coordinator (Festanstellung)
Janssen-Cilag GmbH, Neuss
6/2003 – 6/2007 (4 Jahre, 1 Monat)
Pharmaindustrie
Tätigkeitszeitraum

6/2003 – 6/2007

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Projektmanagement


CRA (Festanstellung)
Janssen Cilag GmbH, Neuss
9/2002 – 5/2003 (9 Monate)
Pharmaindustrie
Tätigkeitszeitraum

9/2002 – 5/2003

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Monitor (CRA), Klinische Studie, Good clinical practice (GCP), Projekt-Qualitätssicherung


Zertifikate

Registered Nutritional Therapist (QUETHEB)
November 2018

Medical Device Safety Officer (TÜV Süd)
November 2017

Auditor in Pharmacovigilance (GQMA)
Oktober 2016

GCP Auditor (GQMA)
November 2014

Certified Quality Management Auditor (QMA TÜV)
Juni 2012

Six Sigma Black Belt
September 2010

Certified Quality Management Representative (QMR TÜV)
Oktober 2009

Ausbildung

Nutrition Science
(Dr. oec.troph / M.Sc. Nut., Ph.D. )
Jahr: 2006
Ort: Rheinische Friedrich-Wilhelms-University Bonn

Qualifikationen

• 18 years of progressive experience in clinical research in pharmaceutical industry and CRO business, thereof 13 years as global project manager.
• Proven global drug development expertise and experience in management of mor than 50 clinical trials (phase Ib-IV, FSMP, NIS)
• Subject matter expert across broad range of therapeutic areas including but not limited to Cardiovascular diseases (AF, PAH, CABG), Nervous System (Epilepsy, Alzheimer’s disease), Anesthesiology (Osteo- and rheumatoid arthritis, Gon- and Coxarthrosis, Malignant pain), Hematology (Multiple Myeloma), enteral/parenteral nutrition in premature born infants and adult patients, and rare disease indications (Autoimmune Encephalitis and Pyridoxine-5'-phosphate oxidase (PNPO) deficiency), psychometric rating scales, questionnaires and patient reported outcomes
• Accomplished expert in business development, change management, and comprehensive operational improvements. Certified Six Sigma Blackbelt.
• Demonstrated success driving innovative strategies for clinical research start-ups in competitive markets.
• History of building and mentoring highly motivated teams across cultures, disciplines, and geographies.
• Certified Quality Management Representative and Auditor with thorough knowledge of clinical nutrition.


Über mich

Results-driven leader and dynamic communicator with strong business acumen and depth of expertise in clinical research. Recognized talent for motivating high levels of collaboration among diverse teams. Creative and intuitive problem-solver with proven ability to rapidly assimilate new knowledge and articulate innovative plans in rapidly evolving landscapes.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
243
Alter
48
Berufserfahrung
18 Jahre und 4 Monate (seit 09/2002)
Projektleitung
18 Jahre

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