Head of Study Nurse Gynaecology / Gynaecological Oncology (m/f/d)

Operational Study Coordination and Management Total Responsibility: Control of the Operational Conduct of Clinical Studies over the entire cycle from initiation to close-out Process control: Monitoring all study-specific processes, visits and deadlines Resource planning: structuring of personnel, rooms and infrastructure for a smooth day of study Interface work: Close cooperation with test physicians, sponsors, CROs and internal clinic departments Quality assurance and compliance Rules: Ensuring strict compliance with regulatory requirements according to GCP, AMG and ICH-GCP Audits & Monitorings: Responsible preparation, coordination and monitoring of monitor visits, audits and government inspections Data quality: continuous monitoring of data integrity and completeness of the study documentation Deviation Management: Early Identification, Assessment and Sustainable Tracking of Protocol Deviations SOP Management and Process Development SOP creation: Development, implementation and continuous optimization of standard operating procedures (SOPs) Process optimization: Standardization and further development of operational study processes Practice transfer: Ensuring the sustainable implementation of defined processes in everyday work Team management and personnel development Head: Professional and disciplinary leadership of the entire study-only team Application planning: Creation of service and deployment plans taking into account study-specific requirements Onboarding: Structured integration and integration of new employees Continuing training: planning and implementation of specific training courses and individual further development measures Team culture: Active promotion of interdisciplinary, value-adding and cooperative cooperation Patient tasks Patient care: Accompanying and educating students, especially in the context of complex study protocols Measures: implementation and monitoring of study-specific interventions and expert sampling Security: Continuous seizure of patient compliance and patient safety Security messages: Timely detection, medical assessment and formal notification of unwanted events (S)AEs)

Qualification Training: Complete training in health care (e.g. nursing, MFA) or comparable medical qualification Additional qualification: Continuing training for the Study Nurse or Student Coordinator (must be acquired if necessary) or a completed study in the field of Care Management / Clinical Research / Natural Sciences Experience: Multiannual, well-founded professional experience in clinical research Knowledge: Deep, safe knowledge of GCP guidelines and clinical trials Methodological and technical skills Project management: Detegratable experience in the clinical environment IT systems: Secure handling of electronic data acquisition systems (EDC) and common study software Clinical know-how: Good knowledge of clinical processes and specific medical terminology Language skills German: German language skills in word and writing English: Very good English skills for secure international correspondence Personal competencies Organization & Communication: Embossed organizational strength and precise, targeted communication skills Working method: High sense of responsibility combined with a structured, solution-oriented working method Enforcement Strength: Enforcement and Diplomatic Skill in Complex Organizational Structures of a University Hospital Soft Skills: High team orientation, empathy in dealing with patients as well as loadability

Everything, except usual: You expect a safe and meaningful job in a challenging working environment where you are always at the heart of time. Job and private life in line with: Thanks to the flexible working time account and desired service plans, you have more time for hobbies, family and friends. Team spirit in R(h)einkultur: You will be welcomed by an interdisciplinary team with open arms that will increase mutual appreciation and helpfulness. Strong perspectives: What other people gain experience across different stations is one of the largest employers in the region under one roof – so you can grow beyond yourself and target new goals. .