Clinical Research Consultant
A personal and tailored
clinical project management service.
Angelika Karwoth GmbH
SERVICES
My mission:
Leading your project to success by providing support and expertise with the following:
Project Management:
- Selecting the right resources for your project – individuals and vendors
- Team lead and vendor management, including measuring performance, quality and finance
- Selecting the right sites in Europe
- Managing your study from Feasibility through start-up and enrollment to Database Lock
- Fiscal management
Data Surveillance:
- Risk-based Monitoring: Development of quality parameters and data surveillance strategies
- Aggregated Data Analytics: Developing data review specifications, review of aggregated data to detect risks and trends, data reconciling
Regulatory/ Ethics:
- Preparation and Submission to Ethics and Regulatory bodies Training
- Planning and conducting Investigator Meetings
- Site / CRA Training
- Motivational Site Visits
Training:
- Planning and conducting Investigator Meetings
- Site / CRA Training
- Motivational Site Visits
Welcome to Angelika Karwoth GmbH
More than 25 years progressive experience in various positions within project management and clinical operations.
10+ years of multi-functional team and project management experience.
Based in Germany, Angelika has international experience working with Pharmaceutical Companies and CRO’s of all sizes with particular expertise and effectiveness partnering with small and mid-sized biotech companies which carry unique resourcing and budgeting considerations. Angelika excels at strategic planning to set and accomplish fit-for-purpose objectives.
Angelika has a strong track record in keeping complex, diverse project teams involving multiple stakeholders together and meeting objectives within timelines and on budget. She prides herself on staying engaged with her Client’s objectives, taking ownership and accountability her assignments and progress.
A flexible, adaptable, and results-oriented leader, Angelika enjoys not only setting strategy, but mentoring and coaching her teams to meet clear objectives. Outside of project teams, Angelika is a certified trainer in ICH-GCP and Study Management courses for Drug Information Association (DIA) Europe.
SERVICES
Presenter:
Study Management and ICH/GCP courses
APEX Clinical Project Manager, EU EMEA
Responsibilities included:
EU EMEA project management (entailing multiple CRO teams), site selection/activation, site/CRA training, fiscal management, development of quality parameters and data surveillance strategies in the context of risk-based monitoring, planning and conducting Investigator Meetings, project wide database lock support (data analytics, manual data review, data review specifications, data reconciling) and compliance tracking (Patient by Patient data cleaning trackers)
- Results-oriented ICU nurse with 25+ years of Global Clinical Development in Pharmaceutical/Biotech plus 10 years of project management.
- Appointments in demanding leadership roles in large and mid-size organizations (Genzyme, P&G, and Portola Pharmaceuticals).
- Extensive clinical development experience (IND/NDA/BLA) in Pharma / Biotech.
- Supported the submission of two NDA/MAA submissions resulting in drug approval in US and EU.
- Hands-on and management experience of large clinical operations groups in late stage, approval-enabling studies.
- Direct negotiations with worldwide vendors.
- Head of EU group comprised country/region specific teams responsible for execution of international studies.
Specialties:
ICH GCP, Project specific Training and Inspection Support.
A selection of previous projects shows a wide range of experience across many major
therapeutic areas:
- Extensive experience in Oncology
- Novel Drug Delivery Methods
- Numerous Phase I Studies
- Gene Therapy
- Infections/ Parasitic Diseases
- Endocrine/ Metabolic
- Haematology
- Circulatory/ Respiratory
- Digestive System
- Neurology
- Fertility
- Gynecology
- Urology
Angelika Karwoth GmbH
Alte BonnerStr 5
53229 Bonn
Germany
Mobile:
Angelika Karwoth GmbH
Alte Bonner Str. 5
53229 Bonn
