Senior Clinical /TrialProject Manager / Medical Advisor Oncology

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74080 Heilbronn
Weltweit
de | en | fr
02.09.2024

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

		 Forschung & Entwicklung (allg.)15 J.
 Good clinical practice (GCP)
 Hämatologie
 Medizin
 MSc Clinical Research
 Onkologie
 Pharmaforschung15 J.
 Phase I-IV
 Projektmanagement
 Variosu Indications

		

Projekt‐ & Berufserfahrung

Senior Manager Clinical Operations 
									IMA-Research GmbH, Schweiz, Deutschland								

4/2017 – offen (7 Jahre, 6 Monate)

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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 (allg.), Pharmaforschung

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, 1 Monat)

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Tätigkeitszeitraum

9/2009 – offen

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Forschung & Entwicklung (allg.), Pharmaforschung

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

1373

Alter

Berufserfahrung

							33 Jahre
							(seit 09/1991)
							

Projektleitung

20 Jahre

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