Freiberuflerin in München: Beratung, Projektmanagement & Training für Klinische Studien und Medical Affairs
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- 80997 München
- Europa
- de | en | es
- 23.10.2023
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
9/2017 – 12/2019
Tätigkeitsbeschreibung
• Medical translations of patient cases, slide decks and publications
• Medical Manager Neurology (interim), Multiple Sclerosis, Autoimmune diseases. Responsible for all Medical Manager tasks, cooperation with Marketing, co-development of marketing material, review and approval of medical and marketing material (Zinc/Veeva Vault Promomats), Non-interventional studies, abstracts/poster, publications, training of Medical Science Liasons and sales, preparation and translation of slide decks, congress update material, Organisation of Advisory boards and Congress symposia
• Medical Manager Cardio-Renal-Therapies, Iron Deficiency Anaemia (interim), s. above
• Medical writing (Advisory board meeting minutes, publications, SOPs)
• NIS Project Management
• Mentoring/Training of new Medical Advisors
• Writing of SOPs
• Translations of Patient cases and e-learnings for continued medical education
Management (allg.)
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
Medizinforschung
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
Projektmanagement
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.
Train the Trainer
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
Projektmanagement
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
Projektmanagement
Ausbildung
Hohenheim
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Weitere Kenntnisse
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Spanisch (Grundkenntnisse)
- Französisch (Grundkenntnisse)
- Europäische Union
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