My services

I support pharma and biotech companies with hands-on expertise in Clinical Operations and Clinical Supply Chain Management across the clinical development lifecycle.

With 25 years of experience in the pharmaceutical industry, I provide senior operational leadership with particular strength at the interfaces between Clinical Operations, Clinical Supply Chain, Regulatory Affairs and other cross-functional disciplines.

From early study planning through execution and close-out, I translate strategy into operational reality – anticipating risks and dependencies, navigating regulatory and operational complexity, and developing pragmatic solutions that keep clinical programs moving.

How I can support you

Set up and management of clinical studies

Study oversight through all study phases (Start-up, Conduct, Close-out)

Assessment of the operational feasibility

e.g. check of country requirements, timelines and budget

Support in contracting

Negotiation of contracts with CROs, Labs, Academic sponsors or other parties, as needed

Development of business processes

Support in development of SOPs and other business processes, as needed

Testimonials

What my clients say

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Ralph J.

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“Ms Hülsen possesses exceptionally profound expertise, which she continuously availed to our company in an effective and highly professional manner.”

Fabrice K.

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“Ms Hülsen is able to grasp and analyze even complex and difficult matters, to develop very good strategies and solutions and to adapt them with remarkable foresight to the specific customer and project requirements as well as to the market development.”

Jessica O.

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"Fabiola was managing the operations for several of our scientific studies in the field of neuroimmunology rare disease. Throughout our collaboration, I got to know Fabiola as a true team player who is always trying to support wherever she can. Her efficient way of working, organisational excellence and strong problem-solving skills were key for the success of our projects and helped us accelerate timelines. Besides her high level of professionalism, Fabiola always managed to bring a friendly and personal atmosphere to our meetings. I very much enjoyed working with Fabiola and can only recommend her as a future colleague!"

Maja P.

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“During her work for our company, she displayed a broad and in-depth knowledge in all areas, where she was able to successfully apply to her work place. We were able to count on Ms. Hülsen at all times, and to rely on her accurate, precise and conscientious work, even during difficult periods.”