Dr. Karin Hesse

- Project Management for national and international clinical trials, phase I-III - Project Management for non-interventional trials - Responsibility for the planning, conduct, and supervision of all operational processes as part of clinical studies - Staff responsibility for an own study team - Reporting to senior management and to external partners - Deputy Head of Division

Involved as one of the pioneers in setting up the European start-up structure for preparing the conduct of clinical studies in Germany and Switzerland. Providing leadership and responsible for staff development; performance evaluation of up to 16 employees of the local RSU team in Germany and Switzerland, specialized in the negotiation of contracts, the submission of clinical trials to ECs and regulatory authorities, resource planning and project allocation.

Head of local Start-up Group, Germany. Leadership role and performance evaluation; project planning and allocation.

Responsible for the set-up of a dedicated Start-up group in Germany. Compiling instructions and guidance documents for internal start-up processes. Worked with sponsors and internal team members to establish regulatory requirements necessary for start-up components of projects.

Additionally, mentor for less experienced clinical staff including; provided assistance to CTL and PM with design of study tools, documents and processes, budget control.

Responsible for site selection, initiation, monitoring and close-out visits for a variety of protocols, sites and therapeutic areas; protocol and related study training to assigned sites; manage ongoing project expectations and issues; control of quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

PH. D. Thesis in theoretical medicine (Dr. rer. med.), Department of Clinical Pharmacology Abschlussnote: magna cum laude "Study of the human receptor binding profile of Ruscus aculeatus L."

Mikrobiologie, Biochemie Diplomarbeit im Fachgebiet Mikrobiologie - Sehr gut "Entwicklung eines Identifizierungsprogramms für die Gattung Bacillus mit Hilfe miniaturisierter, automatisierter Test und EDV-Auswertung"