PhD in Virology. Clinical Research professional with experience in late stage clinical trials covering several therapeutic areas and IMP management.
Aktualisiert am 18.11.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 02.12.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Clinical Research
Clinical Trial Management
IMP management
Good Clinical Practice
Englisch verhandlungssicher
Italienisch
TMF
CRF
Regulatory Affairs
Biotechnologie
aNALYT
Clinical Databases
Good Clinical Data Management Practice
Italian
Muttersprache
English
business fluent
German
beginner

Einsatzorte

Einsatzorte

Bergisch Gladbach, NRW (+50km)
Deutschland, Schweiz
möglich

Projekte

Projekte

6 months
2024-01 - 2024-06

project management in product development projects with focus on Distribution Management (DM)

Clinical Trial Supply Manager (CTS), CTS Subject Matter Expert (SME)
Clinical Trial Supply Manager (CTS), CTS Subject Matter Expert (SME)
  • Steer and co-lead assigned work packages to realize the agreed project goals within time, budget, and quality in the context of Clinical Trial Supply (CTS).
  • Set up Distribution Strategy for (N)IMP and corresponding Materials for specific Clinical Trials (Forecasting, Involvement of Depots, Number of Shipments, IRT System).
  • Assure GxP conform Packaging and Labelling (P&L) and Distribution Management (DM) for Clinical Trials
  • Management of CTS Vendors (Selection/Contracting, Support with Qualification, FPoC for Distributor/CMO)
  • Preparation of relevant documents (Drug Preparation and Administration Manual, Drug Management Plan, Pharmacy Manual)
CureVac Manufacturing GmbH
4 years 3 months
2019-09 - 2023-11

Site Management Associate II - Real World Solutions

  • Recruits and evaluates potential sites in EU for participation in Late Phase Studies (LPS)
  • Performs Essential Document Collection, Review, Maintenance and Close Out activities
  • Performs Study Tracking to ensure that the study files are current, accurate, and complete
  • Liaises with Internal and External Customers to meet project specific goals
  • Lanages Clinical Sites to ensure adherence to the late phase study design
  • Performs Data Review and Query Resolution tasks for assigned sites
  • Follows database closure procedures for freezing, locking, and unlocking Clinical Databases (eCRF / EDC such as Medidata and Marvin)
  • Resolves internal and external clinical issues for client Clinical Research Projects
  • Implements and monitors Post-marketing Studies to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines
  • Coordinates and conducts telephone PSSV, SIV, and COV visits
  • Performs Regulatory Submissions as Country Specialist for Italy
  • Experiences as Mentor for new employees and online instructor in large Instructor-led trainings (ILT).
ICON plc, formerly PRA Health Sciences
Mannheim
3 years 9 months
2015-09 - 2019-05

Virology and Molecular Biology

Ph.D. student
Ph.D. student
Accurate and goal oriented scientific research aimed to investigate the virus-host interplay during early post-entry events of HIV infection. Selected accomplishments:
  • Independent and well-structured way of working
  • Problem-solving and quick learning skills
  • Strong analytical skills developed by using software for statistical and scientific data analysis.
  • Flexibility and managing multiple priorities with strict deadlines.
  • Project management and method development within international environment.
  • Ability to coordinate interdisciplinary project collaborations across various pertise.
  • Presenting scientific objectives at regular bases at international conferences and meetings
  • Training, mentoring and supervision of students and apprentices
  • In-depth knowledge and understanding of scientific analysis and techniques in Virology, Molecular and Cellular Biology with experience in genome engineering.
  • Virus and mammalian cell handling in Biosafety level 3 (HIV).
  • Throughput screening (siRNA, CRISPR, FACS cytofluorometry).
Heidelberg University Hospital
1 year
2014-09 - 2015-08

involvement in early steps of the HIV-1 infection

Research assistant in Virology and Molecular Biology
Research assistant in Virology and Molecular Biology
  • Investigation of novel nuclear envelope-associated proteins for their involvement in early steps of the HIV-1 infection
Frankfurt University Hospital, Institute for Medical Virology
10 months
2013-08 - 2014-05

Tumorvirus-specific Vaccination Strategies

M.Sc. student: Immunology and Vaccinology
M.Sc. student: Immunology and Vaccinology
Investigation of new strategies for the characterization of protecting antigens. Selected
accomplishments:
  • Virus and mammalian cell handling in Biosafety level 2 (HPV)
  • Animal handling (FELASA course)
  • Strong expertise in pseudovirion-based neutralization assay for evaluation of the functional humoral immune response against HPV
Deutsches Krebsforschungszentrum (DKFZ)
5 months
2011-06 - 2011-10

Oncology in collaboration with the clinics

B.Sc. student and research assistant
B.Sc. student and research assistant
  • Investigation of tumor models and patient material to verify the presence of bacteria in direct contact with the epithelium of preneoplastic lesions of colorectal cancer, thus activating the phenomena of inflammation.
University of Florence, Department of Neuroscience, Area of Pharmacy and Child

Aus- und Weiterbildung

Aus- und Weiterbildung

05/2019

Ph.D.

Ruprecht-Karls-Universität, Heidelberg

Thesis: on request


06/2014

M.Sc.

Grade: Summa cum Laude

University of Bologna, Italy

Thesis: on request


12/2011

B.Sc.

Grade: 99/110

University of Florence, Italy.

Thesis: on request


Certificates

FELASA-B: 2013, Federation of European Laboratory Animal Science Associations

Kompetenzen

Kompetenzen

Top-Skills

Clinical Research Clinical Trial Management IMP management Good Clinical Practice Englisch verhandlungssicher Italienisch TMF CRF Regulatory Affairs Biotechnologie aNALYT Clinical Databases Good Clinical Data Management Practice

Produkte / Standards / Erfahrungen / Methoden

Professional Summary

Clinical Trial Supply Manager in product development projects with focus on Distribution Management (DM). Deep experience as Clinical site monitor in late stage (Phase IIIb-IV) clinical trials covering several therapeutic areas: Oncology, Hematological disease, Infertility, Gene therapy, Neurology, Respiratory. Manage mainly in Europe (Italy, UK, Belgium, Czech Rep., Slovakia, The Netherlands, Ireland), but coordinate studies globally (US, EU, and APAC). Analytical and detail-oriented professional with hands-on experience in biotechnology research. Extensive knowledge in the fields of virology, cell and molecular biology. Superior analytical and organisational skills developed by working on projects with strict deadlines. Expert at collaborating with team members for efficient and timely completion of projects as per defined requirements. Excellent communicator of complex data and science. Cultivate positive relationship with individuals of different levels and backgrounds. Comprehensive intercultural and international experiences (Germany, Ireland, Japan) and multi-lingual (fluent in Italian, English and beginner in German). A sponsorship for employment visa in Japan is not required.


Computational skills

  • Microsoft Office? tools (Word, PowerPoint, Excel, Outlook)
  • Scientific analysis tools (Image Lab?, GraphPad Prism, Photoshop)
  • Online research tools (databases, primer design tools, EndNote)
  • Clinical Trial Management Systems (Siebel Clinical CTMS, PSO)
  • Trial Master File Systems (Veeva Vault, NextDocsTMF, PhlexEview)
  • Clinical Databases (xClinical MARVIN, Medidata RAVE)
  • Project Management (ThinkCell)

Einsatzorte

Einsatzorte

Bergisch Gladbach, NRW (+50km)
Deutschland, Schweiz
möglich

Projekte

Projekte

6 months
2024-01 - 2024-06

project management in product development projects with focus on Distribution Management (DM)

Clinical Trial Supply Manager (CTS), CTS Subject Matter Expert (SME)
Clinical Trial Supply Manager (CTS), CTS Subject Matter Expert (SME)
  • Steer and co-lead assigned work packages to realize the agreed project goals within time, budget, and quality in the context of Clinical Trial Supply (CTS).
  • Set up Distribution Strategy for (N)IMP and corresponding Materials for specific Clinical Trials (Forecasting, Involvement of Depots, Number of Shipments, IRT System).
  • Assure GxP conform Packaging and Labelling (P&L) and Distribution Management (DM) for Clinical Trials
  • Management of CTS Vendors (Selection/Contracting, Support with Qualification, FPoC for Distributor/CMO)
  • Preparation of relevant documents (Drug Preparation and Administration Manual, Drug Management Plan, Pharmacy Manual)
CureVac Manufacturing GmbH
4 years 3 months
2019-09 - 2023-11

Site Management Associate II - Real World Solutions

  • Recruits and evaluates potential sites in EU for participation in Late Phase Studies (LPS)
  • Performs Essential Document Collection, Review, Maintenance and Close Out activities
  • Performs Study Tracking to ensure that the study files are current, accurate, and complete
  • Liaises with Internal and External Customers to meet project specific goals
  • Lanages Clinical Sites to ensure adherence to the late phase study design
  • Performs Data Review and Query Resolution tasks for assigned sites
  • Follows database closure procedures for freezing, locking, and unlocking Clinical Databases (eCRF / EDC such as Medidata and Marvin)
  • Resolves internal and external clinical issues for client Clinical Research Projects
  • Implements and monitors Post-marketing Studies to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines
  • Coordinates and conducts telephone PSSV, SIV, and COV visits
  • Performs Regulatory Submissions as Country Specialist for Italy
  • Experiences as Mentor for new employees and online instructor in large Instructor-led trainings (ILT).
ICON plc, formerly PRA Health Sciences
Mannheim
3 years 9 months
2015-09 - 2019-05

Virology and Molecular Biology

Ph.D. student
Ph.D. student
Accurate and goal oriented scientific research aimed to investigate the virus-host interplay during early post-entry events of HIV infection. Selected accomplishments:
  • Independent and well-structured way of working
  • Problem-solving and quick learning skills
  • Strong analytical skills developed by using software for statistical and scientific data analysis.
  • Flexibility and managing multiple priorities with strict deadlines.
  • Project management and method development within international environment.
  • Ability to coordinate interdisciplinary project collaborations across various pertise.
  • Presenting scientific objectives at regular bases at international conferences and meetings
  • Training, mentoring and supervision of students and apprentices
  • In-depth knowledge and understanding of scientific analysis and techniques in Virology, Molecular and Cellular Biology with experience in genome engineering.
  • Virus and mammalian cell handling in Biosafety level 3 (HIV).
  • Throughput screening (siRNA, CRISPR, FACS cytofluorometry).
Heidelberg University Hospital
1 year
2014-09 - 2015-08

involvement in early steps of the HIV-1 infection

Research assistant in Virology and Molecular Biology
Research assistant in Virology and Molecular Biology
  • Investigation of novel nuclear envelope-associated proteins for their involvement in early steps of the HIV-1 infection
Frankfurt University Hospital, Institute for Medical Virology
10 months
2013-08 - 2014-05

Tumorvirus-specific Vaccination Strategies

M.Sc. student: Immunology and Vaccinology
M.Sc. student: Immunology and Vaccinology
Investigation of new strategies for the characterization of protecting antigens. Selected
accomplishments:
  • Virus and mammalian cell handling in Biosafety level 2 (HPV)
  • Animal handling (FELASA course)
  • Strong expertise in pseudovirion-based neutralization assay for evaluation of the functional humoral immune response against HPV
Deutsches Krebsforschungszentrum (DKFZ)
5 months
2011-06 - 2011-10

Oncology in collaboration with the clinics

B.Sc. student and research assistant
B.Sc. student and research assistant
  • Investigation of tumor models and patient material to verify the presence of bacteria in direct contact with the epithelium of preneoplastic lesions of colorectal cancer, thus activating the phenomena of inflammation.
University of Florence, Department of Neuroscience, Area of Pharmacy and Child

Aus- und Weiterbildung

Aus- und Weiterbildung

05/2019

Ph.D.

Ruprecht-Karls-Universität, Heidelberg

Thesis: on request


06/2014

M.Sc.

Grade: Summa cum Laude

University of Bologna, Italy

Thesis: on request


12/2011

B.Sc.

Grade: 99/110

University of Florence, Italy.

Thesis: on request


Certificates

FELASA-B: 2013, Federation of European Laboratory Animal Science Associations

Kompetenzen

Kompetenzen

Top-Skills

Clinical Research Clinical Trial Management IMP management Good Clinical Practice Englisch verhandlungssicher Italienisch TMF CRF Regulatory Affairs Biotechnologie aNALYT Clinical Databases Good Clinical Data Management Practice

Produkte / Standards / Erfahrungen / Methoden

Professional Summary

Clinical Trial Supply Manager in product development projects with focus on Distribution Management (DM). Deep experience as Clinical site monitor in late stage (Phase IIIb-IV) clinical trials covering several therapeutic areas: Oncology, Hematological disease, Infertility, Gene therapy, Neurology, Respiratory. Manage mainly in Europe (Italy, UK, Belgium, Czech Rep., Slovakia, The Netherlands, Ireland), but coordinate studies globally (US, EU, and APAC). Analytical and detail-oriented professional with hands-on experience in biotechnology research. Extensive knowledge in the fields of virology, cell and molecular biology. Superior analytical and organisational skills developed by working on projects with strict deadlines. Expert at collaborating with team members for efficient and timely completion of projects as per defined requirements. Excellent communicator of complex data and science. Cultivate positive relationship with individuals of different levels and backgrounds. Comprehensive intercultural and international experiences (Germany, Ireland, Japan) and multi-lingual (fluent in Italian, English and beginner in German). A sponsorship for employment visa in Japan is not required.


Computational skills

  • Microsoft Office? tools (Word, PowerPoint, Excel, Outlook)
  • Scientific analysis tools (Image Lab?, GraphPad Prism, Photoshop)
  • Online research tools (databases, primer design tools, EndNote)
  • Clinical Trial Management Systems (Siebel Clinical CTMS, PSO)
  • Trial Master File Systems (Veeva Vault, NextDocsTMF, PhlexEview)
  • Clinical Databases (xClinical MARVIN, Medidata RAVE)
  • Project Management (ThinkCell)

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