пропозиції роботи
Agata Lange
Clinical Trial Manager
Kraków,
małopolskie
Dołącz do GoldenLine i obejrzyj pełny profil tej użytkowniczki
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Języki
angielski
biegły
niemiecki
podstawowy
Doświadczenie zawodowe
Clinical Trail Manager (CTM)
Clinipace Worldwide
formerly: Lead Clinical Research Associate with Paragon Biomedical
Responsible for the day to day leadership and management of monitoring services for clinical projects including direct communication and interaction with investigative sites/monitors/sponsors. Delivers monitoring services to Project Management. Serves as backup in the absence of Project Manager. Develops and maintains project specific tools and training materials. Reviews, manages and tracks trip reports. Provides sponsor support and communication for monitoring and the site which includes conference calls, team training and meeting planning. Assists the Project Manager with management and analysis of enrollment, coordination and management of the project budget, grant administration and sponsor invoicing. Prepares and delivers presentations to sponsors/industry.
Responsible for the day to day leadership and management of monitoring services for clinical projects including direct communication and interaction with investigative sites/monitors/sponsors. Delivers monitoring services to Project Management. Serves as backup in the absence of Project Manager. Develops and maintains project specific tools and training materials. Reviews, manages and tracks trip reports. Provides sponsor support and communication for monitoring and the site which includes conference calls, team training and meeting planning. Assists the Project Manager with management and analysis of enrollment, coordination and management of the project budget, grant administration and sponsor invoicing. Prepares and delivers presentations to sponsors/industry.
Lead Clinical Research Associate (LCRA)
Paragon Biomedical
Responsible for the day to day leadership and management of monitoring services for clinical projects including direct communication and interaction with investigative sites/monitors/sponsors. Delivers monitoring services to Project Management. Serves as backup in the absence of Project Manager. Develops and maintains project specific tools and training materials. Reviews, manages and tracks trip reports. Provides sponsor support and communication for monitoring and the site which includes conference calls, team training and meeting planning. Assists the Project Manager with management and analysis of enrollment, coordination and management of the project budget, grant administration and sponsor invoicing. Prepares and delivers presentations to sponsors/industry.
Senior Clinical Research Associate (SCRA)
Paragon Biomedical
Clinical Monitoring of assigned projects and sites in accordance with Sponsor and or Paragon SOPs, Good Clinical Practice, ICH Guidelines, local regulations and additional sponsor requirements. All activities were performed in the interest of subject safety and vigilance against fraud. Participation in departmental and project team meetings.
Clinical Research Associate (CRA)
Responsibilities included: clinical trials monitoring in accordance with the ICH guidelines, current monitor guidelines and SOPs including identifying sites, preparing documentation for necessary approvals, initiating sites and observing recruitment, performing monitoring at sites, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries and reporting the progress of the study on a regular basis. Therapeutic areas
include: pulmonology, cardiology, viral infections and oncology.
include: pulmonology, cardiology, viral infections and oncology.
Clinical Research Associate (CRA)
TTL Clinical
Involved in a set of CRA's tasks including: assessing project feasibility, site qualification, contracting and preparing documentation for necessary approvals, initiating sites, performing monitoring visits according to all SOP/GCP/legal requirements, reporting and providing the sites with full support to facilitate the study conduct. Therapeutic areas included: neurology, gastroenterology/abdominal surgery and pain management.
Project coordinator
Centrum Innowacji, Transferu Technologii i Rozwoju Uniwersytetu (CITTRU - Uniwersytet Jagielloński)
Coordinated a training project for graduates (practice-oriented Master theses responding to the demands of the companies from biotechnology, chemistry and pharmaceutical sector in Małopolska region and post graduate vocational placements with these companies). This included processing the registration of the candidates, identifying the companies, negotiations, reporting the progress of the project, maintenance of the website of the project. Also involved in organising and then moderating the discussions during "Tailor-made meetings" aiming to enhance the cooperation between scientists and pharmaceutical sector. Helped with organising the 4th University for Industry conference "Life Science Krakow".
R&D Team member
TF Instruments GmbH
Involved in several projects aiming to characterise the hydration properties of proteins under isothermal conditions and temperature scans with varying buffer conditions. Responsibilities included URT (Ultrasonic Resonator Technology) base laboratory experiments and comparison of experimental results with the results available in publications. Supplied experimental data needed for the quality control during the manufacture the ResoScan™ Research System (URT based equipment) and was involved in the recognition of the new application opportunities for the ResoScan™ Research System.
My work results were used in two posters presented during American Association of Pharmaceutical Scientists National Biotechnology Conference (18-21 July 2006, Boston, MA, USA):
- High Resolution Characterization of Protein Aggregation and stability by URT Measurements.
- Ultrasonic Resonator Technology: a sensitive new tool to study thermal stability of proteins from low to high concentrations.
My work results were used in two posters presented during American Association of Pharmaceutical Scientists National Biotechnology Conference (18-21 July 2006, Boston, MA, USA):
- High Resolution Characterization of Protein Aggregation and stability by URT Measurements.
- Ultrasonic Resonator Technology: a sensitive new tool to study thermal stability of proteins from low to high concentrations.
Secretary
Helped with organising the "Nano and Giga Challenges in Microelectronics 2004" conference in collaboration with Atomic Scale Design Network and FQS Poland (Fujitsu Group). Responsibilities included: processing the registration of the participants and speakers, providing information about the conference to the participants, arranging and confirming the time of the presentations with the speakers, processing the abstracts (including editorial corrections) submitted for the plenary and poster sessions to produce the conference brochure.
Szkolenia i kursy
Szkolenia wspomagające pracę CRA/SCRA/Clinical Lead /CTM prowadzone przez Paragon Biomedical/Clinipace Worldwide.
Szkolenia wspomagające pracę CRA prowadzone przez trenerów PAREXEL
06.2006 - kurs "Course in Monitoring Clinical Research" prowadzony przez dr Marcina Waltera, TTL Clinical - Kraków, Polska
2005-2006 - kurs języka niemieckiego przygotowujący do egzaminu Zertifikat Deutsch prowadzony przez Volkshochschule Heidelberg - Heidelberg, Niemcy
07.2004 - Kurs "Międzynarodowe Standardy w Ochronie Środowiska", zorganizowany przez Corsair International Environmental Consultants (kurs obejmował również trening miękkich umiejętności, negocjacje, sprawdziany predyspozycji itp.) - Kraków, Polska
2004-2005 - Program stażowy "Kuźnia Kadr Ochrony Środowiska" zoranizowany przez Fundację Wspierania Inicjatyw Ekologicznych - Kraków, Polska
1991-2004 - Kursy języka angielskiego, w International House, a następnie w British Council (egzamin Certificate of Proficiency in English w 2004 roku) - Kraków, Polska
Szkolenia wspomagające pracę CRA prowadzone przez trenerów PAREXEL
06.2006 - kurs "Course in Monitoring Clinical Research" prowadzony przez dr Marcina Waltera, TTL Clinical - Kraków, Polska
2005-2006 - kurs języka niemieckiego przygotowujący do egzaminu Zertifikat Deutsch prowadzony przez Volkshochschule Heidelberg - Heidelberg, Niemcy
07.2004 - Kurs "Międzynarodowe Standardy w Ochronie Środowiska", zorganizowany przez Corsair International Environmental Consultants (kurs obejmował również trening miękkich umiejętności, negocjacje, sprawdziany predyspozycji itp.) - Kraków, Polska
2004-2005 - Program stażowy "Kuźnia Kadr Ochrony Środowiska" zoranizowany przez Fundację Wspierania Inicjatyw Ekologicznych - Kraków, Polska
1991-2004 - Kursy języka angielskiego, w International House, a następnie w British Council (egzamin Certificate of Proficiency in English w 2004 roku) - Kraków, Polska
Edukacja
Biologia (specjalizacja: biochemia), magisterskie
Uniwersytet Jagielloński w Krakowie
Zainteresowania
podróże motocyklowe, narciarstwo, rolki, windsurfing, squash, kolekcjonowanie porcelanowych słoni, gotowanie
Organizacje
Związek Harcerstwa Polskiego - Harcerski Klub Narciarski:
Po spędzeniu kilku lat w 7 Gromadzie Zuchowej "Śnieżynki" i 7 Drużynie Harcerek "Limby" przez jakiś czas byłam przyboczną 243 Narciarskiej Drużyny Harcerzy Starszych "Modrzewie". Uzyskałam też stopień instruktorski - Przewodnika. W harcerstwie ani w HKNie nie działam już czynnie (choć HKN stworzył aktualnie Krąg Wychowanków HKNu), ale "once a scout - always a scout".
Po spędzeniu kilku lat w 7 Gromadzie Zuchowej "Śnieżynki" i 7 Drużynie Harcerek "Limby" przez jakiś czas byłam przyboczną 243 Narciarskiej Drużyny Harcerzy Starszych "Modrzewie". Uzyskałam też stopień instruktorski - Przewodnika. W harcerstwie ani w HKNie nie działam już czynnie (choć HKN stworzył aktualnie Krąg Wychowanków HKNu), ale "once a scout - always a scout".
Grupy
Clinical Research & badania medyczne
Grupa dla wszystkich badaczy, lekarzy, naukowców i ludzi biznesu związanych pośrednio i bezpośrednio z medycyną
MEDYCYNA
[i]Grupa ta powstała aby integrować ludzi zawodowo zajmujących się tematyką usług medycznych. Skierowana jest do osób dynamicznych, którzy już posiadają pozycje na rynku usług medycznych
Rynek Farmaceutyczny
Grupa dla osób profesjonalnie zajmujących się rynkiem farmaceutycznym. Ma na celu wymianę informacji na temat zmian na rynku farmaceutycznym w Polsce jak i za granicą.
