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Senior Clinical /TrialProject Manager / Medical Advisor Oncology

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  • 74080 Heilbronn
  • Weltweit
  • de  |  en  |  fr
  • 02.09.2024
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Kurzvorstellung

>20y advanced Project Management Skills. Clinical Studies loc/reg/glob
Expert proficiency as a SCRA/LCRA >10y
Med Advisor Oncology >3y
Various Therapeutic Areas. All phases & IIts, NIS, CUPs.
Proven record track. Flexible.
"Plug`n Play"

Qualifikationen

  • Drug Discovery15 J.
  • Forschung & Entwicklung15 J.
  • Gute Klinische Praxis
  • Hämatologie
  • Medizin
  • MSc Clinical Research
  • Onkologie
  • Phase I-IV
  • Projektmanagement
  • Variosu Indications

Projekt‐ & Berufserfahrung

Senior Manager Clinical Operations
IMA-Research GmbH, Schweiz, Deutschland
4/2017 – offen (7 Jahre, 8 Monate)
Life Sciences
Tätigkeitszeitraum

4/2017 – offen

Tätigkeitsbeschreibung

Study Management over all- all activities (planning, performance, completion); ensuring target KPIs met; KOL-management; line, budget, and vendor management; ensuring targets met (quality, budget, timelines); reporting (status reports, ad hoc reports); development study strategies, study outlines; consultancy Due Diligence; communication HAs/ECs/IRBs etc.

Eingesetzte Qualifikationen

Forschung & Entwicklung, Drug Discovery

Freelancer Clinical Operations Management
diverse (s. CV), CH, D, UK, UKR, RUS, IT, F, ES, IT, IRE, S, PL, CZ
9/2009 – offen (15 Jahre, 3 Monate)
Life Sciences
Tätigkeitszeitraum

9/2009 – offen

Tätigkeitsbeschreibung

Clinical Project Manager
Senior Clinical Project Manager
Study Manager
Senior Study Manager
Program Manager

Eingesetzte Qualifikationen

Forschung & Entwicklung, Drug Discovery

Zertifikate

Master of Science of Clinical Research
2011

Ausbildung

Clinical Research
Master of Science
2011
Tübingen

Über mich

Thorough knowledge in Health Authority submissions (various countries), EC/IRB, DSMB and promoting Phase I-IV studies in the environment of Big Pharma, Biopharmaceutical companies and CROs. Self-starter, self-motivating, flexible, resilient and well organized expert team player. Leading numerous national and international teams as part of the projects. Strong interpersonal and communication skills, open minded, proactive communication (mentoring, coaching, feedback), integrating and team building spirit. No travel restrictions. Quick adapting to changing requirements, building and fostering contacts to all stakeholders, particularly KOL management, proven outstanding problem solving competences.

Weitere Kenntnisse

Microsoft Office Package (including MS Project)
Expert knowledge in various Clinical Trial and Management Software Applications (e.g. CTMS, IMPACT, RAVE COOL, Syreon, IMFORM, CTP, ACCORD, RUDI, SUSI, NP4 etc.)
Indications:
CNS
Pain, Neurology, Schizophrenia, Major Depressions, Stroke
Cardiovascular (
Hypertension, Ischemic Stroke, Low-Molecular Heparin, Coronary Artery Bypass Graft, Anticoagulation)
Endocrinology
Diabetes type II, Genetic Metabolic disorders
Oncology - Main Focus
Haematology (Non-Hodgkin), Solid Tumors, Non-small Cell Lung Cancer, Melanoma (Skin Cancer), Colocn Cancer, Ovarian Cancer, Rare Tumours
Pediatrics
Genetic Metabolic Disorders: Morbus Pompe, Morbus Fabry
Psychiatry
Schizophrenia (Outcome), Morbus Parkinson, Alzheinmer`s Disease (prodromal), Major Depressions)
Respiratory
COPD, Small Cell Lung Cancer, Pulmonary Artery Hypertension
Virology
Vaccines, Hepatitis C

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Französisch (Grundkenntnisse)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
1418
Alter
55
Berufserfahrung
33 Jahre und 2 Monate (seit 09/1991)
Projektleitung
20 Jahre

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