Clinical and Translational Scientist / CRA

Strong scientific expertise, knowledge in Biomarker / Assay development and IVD studies.
work as :
Clinical study Specialist, Clinical Submission and Team Lead,
CRO Expertise, Site Visits and monitoring, Validation, Assay Transfer etc.

• Biomarker Strategies
• IVDR and GcP
• validation and QC strategies
• clinical studies
• Datenbankrecherche (allg.)
• Good Manufacturing Practices4 J.
• Gute Klinische Praxis3 J.
• Medical Writing3 J.
• Medizinische Versorgung1 J.
• Onkologie
• Projektmanagement
• Projektmanagement - Projektentwicklung4 J.
• Scientific computing / wissenschaftliches Rechnen1 J.

My name is U.. I am working as Clinical Scientist and I am happy to consult in following areas:

-Biomarker development & Management in translational clinical science (CRO management, assay identification, scientific support
-assay validations (method transfer, bridging studies, method comparison)
-clinical study management (study plan, and report, data review, data analysis)
-management of performance studies according to IVDR (including monitoring, site identification and oversight, CRF, ICF, data review, TMF filing etc)
-clinical submission (identification of required documents, point of contact of ethics , communication to ethics etc)

I bring a strong scientific background in oncology, immune-oncology and cell therapy, familiarize quickly with new topics. I work solution-orientated and bring an analytical, strategic and scientific thinking and approach to address my tasks.

-work in clinical studies I-III (Pharma and medical devices (IVD))
-Biomarker development and validation (bridging studies, method comparison, CRO management, assay transfer etc)
-IVD performance studies (CPSP, data analysis, QC, validation of assays)

-work as clinical research associate:
- site identification and initiation
-site monitoring
-staff training
-and set up off required documents: TMF, ISF; CRF, SOP, ICF
data review and reporting

-contact to regulatory authorities

-broad hand on experience in several biological, molecular technologies (Flow Cytometry, LBA, Cell culture, Viral work, animal studies, DNA/ RNA, IHC)

found in profile qualification
Training in:
-R-statistics
-GMP/ GCP practice
-Knowledge of ISO 13485, ISO 15189, 14917
-QC Management in medical device industry
-MQ1 certificate (Medizindidaktische Fortbildung)
-Project management
-4GenTSV biological safety for projectmanagers

Experience
04/ 2021- 12/2024: SUBJECT MATTER EXPERT,
Freelance position (part -time)
Major function: CRO Management, Vendormanagement, bioanalytical support based on guidelines, scientific support for multiplex ligand binding platform, support of clinical development Phase I-IV, Biomarker validations, regulatory compliancy
Topic: soluble biomarkers in disease, oncology, immune-oncology

02/ 2023- 05/2024: CLINICAL RESEARCH ASSOCIATE
Freelance position
Major function: review of CPSP and reports, SetUp of required documents and document maintenance (TMF/ ISF, CRF etc.), Site Monitoring, Data review and analysis, study start up and closure, communication to relevant regulatory authorities, regulatory compliancy

05/ 2022- 10/2023: TEAM LEAD CLINICAL TRIALS,
Limited position
Major function: management of performance studies, coordination of scientists, set up of validation strategies, QC, SOPs, and planning of new projects with regard to timelines and approaches, regulatory compliancy
infectious disease, NGS sequencing

08/ 2021-12/ 2021 SENIOR SCIENTIST, R&D
Freelance position
Major function: data analysis and interpretation, literature research, preparation of scientific hypothesis, project planning and implementation, Vendormanagement, management of scientific cooperation and experimental set ups, set up of MoA studies, Biomarker research, set up of translational approach
Topic: biomarkers in radiation and chemotherapy

07/ 2019-12/ 2020 SENIOR SCIENTIST,
Cell Therapy and Immunology R&D
Major function: assay development for platform processes, Teamlead, scientific writing (grants, publications), data analysis, reports, representation of the department in meetings with pharma-customers or scientific partners. SOP writing, planning translational approaches
Topic: Cancer stem cells in oncology, immune-oncoloy, oncology