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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.
ICH GCP, Project specific Training and Inspection Support.
"As a Director of Clinical Operations at Portola, I worked with Angelika while she managed and oversaw multiple CRO entities executing a large event driven trial for Portola Pharmaceutical's factor Xa inhibitor. The region under her purview included countries within East Europe, West Europe and S. Africa.. As she was responsible for the largest enrolling region entailing the largest quantity of countries compared to other regions within the global (34 country ) 7500 pt trial, she played a pivotal role in the success of this trial. Her responsibilities included (but were not limited to): regional project management (entailing multiple CRO teams), site selection/activation, site/CRA training, monitoring, fiscal management, project wide database lock support (e.g. query tracking and listing review ), and compliance tracking. Simplistically speaking, the best way to describe Angelika's work style is to basically state that "she owns it". In more tangible terms, this is represented by her ability to take full accountability for the quality of execution arising from her region in terms of site performance and exceptional monitoring oversight . Whether the issue at hand on any given day was site activation targets, site compliance for key endpoint data, query resolution, or completion of tasks required to achieve a study milestone; she was/is able to hear, communicate and ultimately deliver it to the sponsor team efficiently and correctly. Her strengths are many; however, she has a keen sense of what to prioritize along with the ability to communicate it strategically to the key individuals within her vast team network. Her directives take root rapidly which in turn produces accurate results for the sponsor. These attributes are all assets and necessities for any project manager. This is why she comes with my highest recommendation."
"I had a very nice and very efficient collaporation with Angelika. She was my project Manager for more than 3 years and I really enjoyed Angelika's professionalism."
Angelika Karwoth GmbH
Alte Bonner Str. 5
0049 171- 35 78 504
Angelika Karwoth GmbH