Freiberuflerin in München: Beratung, Projektmanagement & Training für Klinische Studien und Medical Affairs

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  80997 München
 03.07.2018

Kurzvorstellung

20 jährige internationale Erfahrung in amerikanischen, japanischen und holländischen Pharmaunternehmen in den Abteilungen Klinischen Studien, Training und Medical Affairs, promovierte Naturwissenschaftlerin

Ich biete

Management, Unternehmen, Strategie
  • Management (allg.)
    1 Jahr, 4 Monate Erfahrung

Forschung, Wissenschaft, Bildung
  • Klinische Studie
  • Medizin

Projekt‐ & Berufserfahrung


Neugründering, München
4/2017 – offen (1 Jahr, 4 Monate)
Life Sciences
Tätigkeitszeitraum

4/2017 – offen

Tätigkeitsbeschreibung

Neugründerin zum 1. April 2017

Eingesetzte Qualifikationen

Management (allg.)


Manager Medical Affairs Cardiovascular & Antithrombotics (Director level)
Daiichi Sankyo Europe GmbH, München
5/2012 – 9/2016 (4 Jahre, 5 Monate)
Life Sciences
Tätigkeitszeitraum

5/2012 – 9/2016

Tätigkeitsbeschreibung

Responsible for:
• EU affiliates in France, Spain, Italy, Portugal, UK, Ireland, Benelux, Germany, Austria, Switzerland and Turkey regarding medical projects and communication strategy for Efient (Prasugrel).
• Organisation of training for affiliate medical advisors and medical scientific liasons
• Co-chair of the JESAC committee and voting member for EU medical in the global Efient Joint Research Committee, in charge of financial support of investigator-initiated study proposals
• Organisation of advisory boards, medical education programs and symposia at international congresses
• Budget responsibility
• Network and personal contact with international Key Opinion Leader
• Cooperation with Medical Information, Marketing, Market Research, Public Relations, Clinical Operations

Eingesetzte Qualifikationen

Medizinforschung


International Project Leader
Daiichi Sankyo Europe GmbH, München
7/2009 – 4/2012 (2 Jahre, 10 Monate)
Life Sciences
Tätigkeitszeitraum

7/2009 – 4/2012

Tätigkeitsbeschreibung

Responsible for leading an European cross-functional alliance team evaluating investigator initiated trial (IIT) proposals in the cardiovascular indication, definition of team processes, organisation and moderation of meetings, and budget responsibility. Implementation of approved IITs including contracting, organisation of investigational medicinal product, supervision and advising of
local project managers. Interim DSE representative in the global alliance trial planning committee. Project management of a pan-European non-interventional study with 4000 patients including leadership of the study Steering; European project management of a global Phase IV study.


In addition the following medical responsibilities were taken over in a cross-functional joint brand team:

Implementation of parts of the Brand Plan with regards to IITs and continued medical education, organisation of symposia and and contracting of key opinion leaders, organisation of training meetings for Medical Managers/Advisors of the European affiliates, and attendance at advisory board meetings

Eingesetzte Qualifikationen

Projektmanagement


Global Training Manager (GCP, CRA) & International Project Leader
N.V. Organon, München
5/2006 – 6/2009 (3 Jahre, 2 Monate)
Life Sciences
Tätigkeitszeitraum

5/2006 – 6/2009

Tätigkeitsbeschreibung

Responsible for evaluation of training needs, advising line management, development/maintenance of courses and knowledge tests, implementation of e-learning, training schedules, evaluation of training quality, international team leader for trainers from global Monitoring and global QA.
Development and global workshop leader of a 3-day “Advanced course – GCP compliance Monitoring” training for experienced CRAs in cooperation with global QA.
The training courses focussed on GCP guidelines and company procedures for CRAs and CRMs and were targeted to maintain and improve the quality of the monitoring organisation and to prevent frequent audit findings.

Training and team leadership
• Global team leader for trainers in eCRF (electronic Case Report Forms) software and processes; responsible for build-up and training of a worldwide trainer-team, training schedules, and development of courses.
• Local trainer for computerized systems.
• Trainer in the 5-day global GCP/SOP workshop for new CRAs; after 2 workshops assignment as global workshop leader. Responsible for worldwide harmonized course content, training, coordination and coaching of trainers, workshop moderation, and execution of training modules.

Eingesetzte Qualifikationen

Train the Trainer


Internationaler Projektmanager und Senior CRA
Organon GmbH, München
7/1999 – 6/2009 (10 Jahre)
Life Sciences
Tätigkeitszeitraum

7/1999 – 6/2009

Tätigkeitsbeschreibung

Project management and team leadership
• International project manager for CRAs and team member in the clinical trial project management team (Clinical Trial Team CRA) for several trials with up to 2000 subjects.
• International project manager for Clinical Trial Team CRAs on project level for two drug development projects.
• International trial team co-leader for a high-priority, multi-country, pivotal, proof-of-principle trial with central project responsibility and coordination of all involved departments.
• Local project leader (lead CRA) for numerous trials with up to 40 sites in the German-speaking countries in different indication areas.
• Local Contract Research Organization (CRO) manager at the German subsidiary of the International Monitoring Organisation.

Quality control, process management, and team leadership
• Author, trainer, training coordinator, and team leader of authors for local and international operating procedures; responsible for defining standards for clinical operations.
• As local project leader responsible for quality control (e.g. QC visits, Visit Report Review), supervision and training of internal and external CRAs, SAE Reporting.
• SOP reviewer, GCM-QA Consensus team member
• GCP and SOP consultant in the department

Eingesetzte Qualifikationen

Projektmanagement


CRA
Organon GmbH, München
7/1997 – 7/1999 (2 Jahre, 1 Monat)
Life Sciences
Tätigkeitszeitraum

7/1997 – 7/1999

Tätigkeitsbeschreibung

Trial site management
• Selection of trial sites and pre-trial visits
• Discussion of trial draft protocols with potential investigators and opinion leaders
• Commenting on draft trial protocol and CRF
• Development and implementation of recruitment strategies
• Financial negotiations, contracting and payment of sites
• Submissions to Ethical Committees and Competent Authorities
• Green-light procedure
• Initiation of trial sites
• Monitoring paper and electronic CRFs
• Closeout visit
• Trial documentation file management and archiving
• Destruction of investigational medicinal product

Eingesetzte Qualifikationen

Projektmanagement


Ausbildung

Ernährungswissenschaften
(Dr. rer. nat.)
Jahr: 1998
Ort: Hohenheim

Qualifikationen

Internationales Projekt Management, Klinische Studien Phase I-IV, Late-Phase Studien (NIS, Register, Investigator Initiierte Studien), Training (GCP; Studienstart, Studienergebnisse, Medical), Medical Affairs (Medical Advisor)

Über mich

Meine Stärken sind: Hohe Qualität, teamfähig, lösungsorientiert, strukturiert, pro-aktiv, zuverlässig, schnelle Auffassungsgabe, flexibel

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Spanisch (Grundkenntnisse)
  • Französisch (Grundkenntnisse)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
494
Alter
49
Berufserfahrung
21 Jahre (seit 07/1997)
Projektleitung
13 Jahre

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