freiberufler Clinical Project & Site Management auf freelance.de

Clinical Project & Site Management

offline
  • auf Anfrage
  • 48163 Münster
  • Weltweit
  • de  |  en  |  fr
  • 21.08.2015

Kurzvorstellung

CLIPS - Clinical Project Services ®: conduct of, and independent consulting for all or any operational aspects of a clinical trial

Project Management (Study setup, applications, conduct); Site Management (Monitoring/Supervision); Scientific Writing

Qualifikationen

  • Business Development
  • Compliance management
  • Management (allg.)
  • Medizinforschung
  • Projektmanagement
  • Risikomanagement
  • Schulung / Coaching (allg.)
  • Sprache (allg.)
  • Übersetzung
  • Unternehmensberatung

Projekt‐ & Berufserfahrung

(Contract) Clinical Project Manager
Proinnovera GmbH, Muenster
1/2011 – 9/2011 (9 Monate)
Clinical Research Organisation
Tätigkeitszeitraum

1/2011 – 9/2011

Tätigkeitsbeschreibung

Project Management of two Phase III-studies (Dermatology / Oncology)

Head of Project Management / Lead Project Manager
Proinnovera GmbH, Muenster
4/2009 – 12/2011 (2 Jahre, 9 Monate)
Clinical Research Associate
Tätigkeitszeitraum

4/2009 – 12/2011

Tätigkeitsbeschreibung

 planning and supervising setup and conduct of individual studies managed by other PMs - professional lead & trainer for 14 PMs (GCP- and operational trainings);
 supporting General Management with "Requests for Proposals" & "Requests for Information", preparation of & attendance at Bid Defense Meetings & similar Business Development activities esp. for international trials;
 further activities: regular EC-certified GCP-trainings for investigators / site staff; investigational site pre-study visits; supervising study feasibilities

(Festanstellung / permanent position)

(Contract) Regional Study Manager
Wyeth Pharma GmbH, Münster
2/2008 – 6/2010 (2 Jahre, 5 Monate)
Pharmaceutical Company
Tätigkeitszeitraum

2/2008 – 6/2010

Tätigkeitsbeschreibung

Local clinical Project Management (Germany and/or Austria) in international / global Phase IV- (Dermatology / Rheumatology) and Phase III- (Vaccine / Oncology) trials.

Project Manager
Proinnovera GmbH, Muenster
10/2007 – 12/2011 (4 Jahre, 3 Monate)
Clinical Research Organisation
Tätigkeitszeitraum

10/2007 – 12/2011

Tätigkeitsbeschreibung

 study setup - planning, site- & vendor-feasibilities; assist with costings & contracting; prepare / review Clinical Trial Documents; CTA / Amendments / Notifications (Ethics & Regulatory); organize Investigator Meeting; coordinate project / team / vendor / site start activities;
 study conduct & management - team, site & documents management, co-monitoring visits / for-cause monitoring visits; controlling of budget, quality and timelines; oversee risk management plan;
 study wrap-up - plan & coordinate data cleaning activities with DM, organize BDRM, review SAP, CSR etc.; site close-out activities, incl. notifications to official bodies

(Festanstellung / permanent position)

(Contract) Project Manager
TKL research Inc., Germany / USA
4/2005 – 7/2012 (7 Jahre, 4 Monate)
Clinical Research Organisation
Tätigkeitszeitraum

4/2005 – 7/2012

Tätigkeitsbeschreibung

facilitated cooperation between Proinnovera GmbH and TKL research Inc. (2005-2011);
supporting with "Requests for Proposals" & "Requests for Information", (country) feasibilities, preparation of & attendance at Bid Defense Meetings & similar Business Development activities esp. for international trials (formerly as employee with Proinnovera, since 2012 on a freelance basis)

Study Manager
Proverum GmbH, Münster
1/2005 – 9/2007 (2 Jahre, 9 Monate)
Clinical Research Organisation
Tätigkeitszeitraum

1/2005 – 9/2007

Tätigkeitsbeschreibung

Management of Clinical Trials, incl. interaction with Regulatory; additional duties: assistance international Business Development
(Festanstellung / permanent position)

Clinical Research Associate
Proverum GmbH, Muenster
2/2001 – 1/2005 (4 Jahre)
Clinical Research Organisation
Tätigkeitszeitraum

2/2001 – 1/2005

Tätigkeitsbeschreibung

full Monitoring of phase II - IV trials, incl. vaccine studies, epidem. studies, unblinded Monitoring; additional duties: assistant study manager, medical writing
(Festanstellung / permanent position)

Zertifikate

Heilpraktiker für Psychotherapie
2012

Ausbildung

Biologie
Diplom / Promotion
1995
Muenster

Über mich

I am offering national/international project management for your clinical trial. Much experience in study start-up activities (Clinical Trial application to EC and CA!). For monitoring tasks, regional assignement is preferred.
Experience in Phase II, III, and IV studies; main indications: oncology, dermatology, vaccine, rheumatology. Details & full project list, together with CV will be made available upon request.

Memberships
•DGGF (active involvement in the GCP-work group)
•CRA-net

Weitere Kenntnisse

•Site Management: site selection and all or any aspects of site management during ongoing study: in-house monitoring, monitoring visits & reporting, remote support for sites
•Study Management: manage activities related to an assigned clinical trial on behalf
of the sponsor (pharmaceutical company or investigator) or CRO, including feasibility, set-up (e.g. CTAs to EC and CA), conduct and wrap-up, as well as TMF-maintenance
•Team Management: coordinate internal project team and consulting groups (if appl.), communicate with sponsor project management, ensure roles and responsibilities, as well as goals and targets are clear across internal and external organizations;
experience in working with functional groups i.e. DM/Biostatistics, Medical writing, Medical monitoring/Safety, Regulatory Affairs, etc.
•Budget & Risk Management: oversight over timelines, budget, team performance
- manage project metrics and, if necessary, develop CAPA and mitigation
•Information Management: trainings on ICH-GCP / AMG / GCP-V, on any and all operational aspects of a clinical trial, on selected scientific topics (e.g. laws & regulations, human physiology, psychopathology, systemic counselling)
•Documents Management / Scientific Writing: preparation / review of ICF, Protocol, Clinical Study Report (CSR), Manuals & additional instructions; independant quality check of Trial Master File (TMF); scientific publications, presentations and literature research

•all Office Applications (up to and including version 2010)
•various eCRFs and Clinical Trial Management Systems

•regular certified trainings in ICH-GCP, AMG, GCP-V

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Französisch (Grundkenntnisse)
  • Spanisch (Grundkenntnisse)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
2391
Alter
55
Berufserfahrung
23 Jahre und 1 Monat (seit 02/2001)
Projektleitung
7 Jahre

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