Kristin Werner

I am managing pre- and post-marketed clinical studies from strategy discussions to study set up, conduct and closure. I am responsible finalizing each project within the budget and timelines and select and manage vendors and further leading and training the intercultural clinical study operations team assigned to each project. Further I am writing SOPs and support the implementation of new regulations in our daily business. Besides supporting colleagues I am a line manager for interns.

Clinical project manager responsible for leading and supervising global interdisciplinary core teams to achieve effective and efficient medical device study execution meeting timelines, milestones and budget. Liaise with internal stakeholders, medical directors, therapeutic area experts, vendors and key opinion leaders. In charge of study status reporting and budget / timeline oversight. Serve as an integral part for development, coordination, execution and operational management of studies.

Organizing and managing medical device studies (class IIb) : Scientific input for study design and protocol development; creation, compilation and submission of all study documentation to competent authorities / ethics committees; liaison with academic investigators and external vendors; evaluation of recruitment strategies; development of study related plans; medical device and equipment supply; safety management set up with SAE reporting procedures; involved in data evaluation and interpretation

Responsibility as project lead for the implementation and management of international clinical trials for stroke prophylaxis, acute heart failure, elective coronary intervention, acute STEMI and acute Sepsis: CRA training and oversight, site set up, preparation of submission documentation, input to protocol and monitoring plans, main contact person for sites, sponsor and vendors, audit preparation, support during conduct / follow up, support employee training, presentation at investigator meetings

Development of a molecular method (qRT-PCR) to identify the germ Listeria in bacterial culture and food

Attendance at the daily inspection work of a food surveillance officer, responsibility of administrative and organizational duties.

Planning and initiation of new product lines at the manufacturing base, statistical data collection of manufacturing errors. Participation at the daily work for quality assurance and product development

Designing, coordination, documentation, accomplishment and analysis of an interventional human study: literature review, protocol and informed consent form writing with submission to the ethics committee, timely conduction of the study, data collection and analysis, writing up study results

Main focus on biomedicine science courses: • Molecular physiology and pathophysiology • Immunology • Disease and treatment • Oncology • Pharmacology • Toxicology • Human genetics • Epidemiology and design of experiments • Practical lab courses in various life science departments

Natural scientific basic studies and practical courses in various life science departments Physiology and anatomy including practical courses; Nutrition physiology, - metabolism and medicine; Food chemistry, - technology; Food toxicology; Biostatistics; Basic methodology in scientific working