Uwe Becker - Senior Medical Liaison / Senior Clinical Research Associate
Experience
SCRA
Parexel US
- Perform site qualification, site initiation, interim monitoring, site management and close out visits on site or remotely ensuring regulatory, ICH-GCP, GPP and protocol compliance
- Evaluate overall performance of site and site staff and provide recommendations regarding site specific actions
- Communicate and escalate serious issues to project team and develop action plans
- Verify the process of obtaining informed consent is adequately performed and documented for each subject
- Demonstrate diligence in protecting the confidentiality of each patient
- Assess site processes
- Conduct source document review of appropriate site source documents and medical records
- Verify clinical data entered in CRF is accurate and complete via review of site source documents and medical records
- Apply query resolution techniques remotely and on site and provide guidance to site staff to drive query resolution to closure within agreed timelines
- Utilize available hardware and software to support effective study data review and capture
- Verify site compliance with electronic data capture requirements
- Act as primary liaison with project site personnel or collaborate with central monitoring associate to ensure all assigned sites and project specific site team members are trained and compliant with applicable requirements
- Understand project scope, budgets and timelines for own and other activities
- Adapt quickly to changing priorities to achieve goals and targets
- Prepare and attend investigator meetings and sponsor face-to-face meetings
Homecare for my father (cancer patient)
CRA II
Syneos Health
- Phase IV neurology study for AstraZeneca
MSL (contract)
Swedish Orphan Biovitrium Germany
- Rare disease (Hereditary ATTR-amyloidosis)
CRA II
GCP Bremen
- Phase IV neurology/MS study for Novartis
Senior MSL
Ultragenix Inc.
- Ultra rare disease muccopolysaccharidosis (grade IV)
Senior MSL
BioMarin Pharmaceuticals
- Primary interface between client and clinical trial sites across all development programs
- Work closely with clinical development and clinical operations to ensure successful execution of high quality clinical studies
- Advise and participate in planning and set up of clinical trials
- Develop deep scientific expertise across therapeutic areas (MPS grade IV, ultrarare disease)
Senior MSL
Apellis Pharmaceuticals
- Contract 6-12 months
- PNH, hematology and rare disease
Country Lead MSL Early Access Programs
Impatients N.V.
- Hematology (B- and T-cell lymphoma, MDS)
- Neurology (Parkinson disease)
- Immunology and rare disease
- Team and KOL management (G-ALL study group)
- Named patient programs (NPPs)
- 70% medical affairs and 30% market access
Senior MSL
Genzyme Inc.
- Solid organ transplant (kidney, liver, heart, lung)
- Islet cell transplantation in diabetes I
MSL Oncology/Nephrology
Amgen Germany
Scientific employee, Department of Immunology
Roche AG Germany
Scientific employee
Marine Research Institute Flødevigen
- Monitoring environmental contamination in open oceans and coastal regions of Norway
Industry Experience
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Experienced in Biotechnology, Pharmaceutical, Government and Administration, and Healthcare.
Business Area Experience
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Experienced in Research and Development, Quality Assurance, and Operations.
Summary
Extensive knowledge in oncology/hematology (solid tumors, BMT, stem cell tx) SOT (solid organ tx), nephrology (CKD), immunology, rare & ultra-rare diseases, infectious diseases Market knowledge in the DACH region, 29 years of work experience, Experience with "Early Access" procedures Certificate as Clinical Research Associate (CRA; SCRA)
Skills
- Ms Office - Word
- Excel
- Ppt
- Osx
- Linux
Languages
Education
Master in biochemistry, university degree · Biochemistry
Certifications & licenses
Clinical Research Associate
Pharma -Academy Bremen
Statistics
Experience
Expertise
Qualifications
Profile
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