freiberufler Experienced Clinical Science Consultant - Pharma & Biotech auf freelance.de

Experienced Clinical Science Consultant - Pharma & Biotech

offline
  • auf Anfrage
  • 16515 Oranienburg
  • Weltweit
  • de  |  en  |  ru
  • 27.03.2022

Kurzvorstellung

Experienced Clinical Science Consultant skilled in R&D, clinical trials devolopment, planning and management. Broad range of indications including oncology, MSK, autoimmune diseases, infections and rare diseases. Translational, early and late phase.

Qualifikationen

  • Angewandte Forschung
  • Forschung & Entwicklung (allg.)
  • Klinische Studie
  • Projekt-Qualitätssicherung
  • Projektmanagement
  • Projektmanagementberatung

Projekt‐ & Berufserfahrung

Consultant Clinical Sciences
Kundenname anonymisiert, Home-based
1/2022 – offen (2 Jahre, 3 Monate)
Life Sciences
Tätigkeitszeitraum

1/2022 – offen

Tätigkeitsbeschreibung

- Review and analysis of availble data (in vitro, in vivo and clinical) for clinical development and set-up of new potential compound
- Scientific input and state-of-the-art summary for development and study planning

Eingesetzte Qualifikationen

Angewandte Forschung, Klinische Studie

Senior Clinical Scientist
CureVac, Frankfurt/Tübingen; homebased
10/2020 – 8/2021 (11 Monate)
Life Sciences
Tätigkeitszeitraum

10/2020 – 8/2021

Tätigkeitsbeschreibung

- Planning and executing high-quality and state-of-the-art clinical immunomonitoring/biomarker programs to enable projects to achieve clinical milestones
- Write immunomonitoring/biomarker plans as part of clinical development plans
- Preparation and review of clinical study documents and protocols
- Providing analysis, interpretation and integration of immunomonitoring/biomarker data into regulatory documents/study reports and publications
- Preparing presentations of immunomonitoring/biomarker results for scientific conferences, stakeholder meetings and advisory boards
- Co-accountability for bringing compounds across all therapeutic areas from preclinical research through clinical development by applying state-of-the-art biomarker and translational approaches

Eingesetzte Qualifikationen

Angewandte Forschung, Forschung & Entwicklung (allg.), Klinische Studie, Qualitätsmanagement (allg.)

Consultant Clinical Sciences
Kundenname anonymisiert, Berlin area
6/2020 – offen (3 Jahre, 10 Monate)
Life Sciences
Tätigkeitszeitraum

6/2020 – offen

Tätigkeitsbeschreibung

• Expert consultancy services on clinical development and at individual study level including planning, preparation, management and coordination, analysis and publication of results
• Phase 1-3, early and translational
• Preparation and review of clinical study documents and protocols
• Oversight and coordination of the preparation of documentation for regulatory submissions investigator brochures, protocols, and clinical study reports)

Eingesetzte Qualifikationen

Angewandte Forschung, Klinische Studie, Projektmanagement, Projektmanagementberatung

Clinical Scientist (Festanstellung)
Mologen AG, Berlin
12/2017 – 5/2020 (2 Jahre, 6 Monate)
Biotech/Pharma
Tätigkeitszeitraum

12/2017 – 5/2020

Tätigkeitsbeschreibung

• Provide state of the art scientific input to strategy planning, and for evaluation and interpretation of pre-clinical and clinical data
• Assist and complement the Director Clinical Sciences in assuring Sponsor's responsibilites in terms of medical/scientific due diligence according to current regulations
• Support, coordinate and manage interaction and collaboration with international/external stakeholders and vendors
• Development of and scientific support on clinical development plan, study protocol, investigator's brochure, clinical study report and other relevant documents for development and execution of clinical studies
• Scientific and in person support for meetings and workshops with investigators, consultants and monitors
• Provide training and scientific input to clinical operation’s colleagues and prinicipal investogators, site staff, and serve as trouble-shooter and expert on clinical and scientific support for medical issues and aspects of assigned studies
• Scientific support for study reports and preparation of materials for use in presentations and advisory committee meetings, and provision of response to regulatory agency questions
• Scientific support of business development; co-ordination, preparation, and review of study results for publications, abstracts, poster presentations and scientific meetings

Eingesetzte Qualifikationen

Angewandte Forschung, Klinische Studie, Projekt-Qualitätssicherung

Clinical Project Manager (Festanstellung)
PAREXEL International, Berlin
9/2012 – 11/2017 (5 Jahre, 3 Monate)
Biotech/Pharma
Tätigkeitszeitraum

9/2012 – 11/2017

Tätigkeitsbeschreibung

• Management of clinical trials including study budget management and identifying, assessing and contracting suppliers of central pharmacy and regional lab services
• Organizational and in-time planning including monitoring of projects and project courses with the departments of PAREXEL and external units, as well as realization of management decisions
• Close communication with sponsors and stakeholders, conduct of project related meetings
• Manage international teams for the design and development of tailored clinical trial application including tracking, analysis and data export applications, and associated validation
• Lead cross-functional study teams to deliver services in time and budget
• Monitoring and organization of study performance taking into consideration national and international guidelines (AMG, GCP, FDA regulations, ICH-guidelines)
• Manage internal and external stakeholders (e.g., clients, KOLs, study sites)

Eingesetzte Qualifikationen

Klinische Studie, Projekt-Qualitätssicherung, Projektdurchführung, Projektmanagement

Research Scientist (Festanstellung)
SigN, A-STAR, Singapur
12/2008 – 12/2011 (3 Jahre, 1 Monat)
Life Sciences
Tätigkeitszeitraum

12/2008 – 12/2011

Tätigkeitsbeschreibung

• Management and coordination of translational/early phase trials, including “Isolation of untouched regulatory T cells” for the treatment of GvHD in a phase I/II clinical trial
• Setup of protocol for isolation and adoptive transfer of human regulatory T cells for clinical application, SOPs and quality assurance
• Coordinating the project in cooperation and liaison with the pre-clinical development platform at SIgN, research companies, clinicians and authorities
• Conduct several research projects in human immunology, molecular genetics and oncology
• Training and supervision of students and Ph.D. students

Eingesetzte Qualifikationen

Angewandte Forschung, Forschung & Entwicklung (allg.), Klinische Studie

Zertifikate

GCP Certificate
2021

Ausbildung

Animal Sciences
Doktor
2001
Berlin
Animal Sciences
Diplom
1998
Berlin

Über mich

• Expert consultancy services on clinical development and at individual study level including planning, preparation, management and coordination, analysis and publication of results
• Phase 1-3, early and translational
• Preparation and review of clinical study documents and protocols
• Oversight and coordination of the preparation of documentation for regulatory submissions investigator brochures, protocols, and clinical study reports)

Weitere Kenntnisse

• Doctoral degree in Natural Sciences
• Over 10 years experience in clinical sciences and operations; planning, coordination and management of clinical studies in pharmaceutical and biotechnology companies as well as pre-clinical and translational projects
• Effective communicator with good analystical and problem-solving skills
• Pro-active and flexible
• Strong organizational skills
• Self-motivated
• Experienced team leader in a global and multicultural environment

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Russisch (Grundkenntnisse)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
402
Alter
53
Berufserfahrung
15 Jahre und 3 Monate (seit 12/2008)
Projektleitung
10 Jahre

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