As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis. Our aim: to meaningfully improve therapeutic practice as well as patient health and well-being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for: Clinical Project Manager Early Clinical Research - Pharmacology (m/f/d) Responsibilities Strategic planning, execution, and oversight of international Phase I clinical trials in accordance with GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA), and internal SOPs Preparation, review, and approval of all relevant study documents in collaboration with external service providers Contract negotiations with external service providers (CROs, central laboratories) as well as planning and monitoring of study budgets and timelines Responsibility for risk management and sponsor oversight within the studies Analysis and interpretation of study results as well as review and assessment of clinical study reports Leading project-specific study team meetings Supporting the clinical research department with questions related to clinical pharmacology Providing input on strategic strategies for development programs, including collaboration with industry and academic partners Supporting the evaluation of development projects and assessment of new product candidates Supporting the preparation of regulatory submissions and handling regulatory inquiries on clinical pharmacology topics Contributing to quality assurance activities (creation and revision of SOPs; preparation and execution of audits) Benefits Supportive, respectful and appreciative work atmosphere in a small, dedicated team Diverse learning culture and individual development opportunities International and growing family business with short decision-making processes, financial independence and long-term perspective New work, flexible working hours and mobile working Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad) Comprehensive onboarding and mentoring program In addition to adequate remuneration, we offer a secure and interesting job in a competent and open-minded team. If you have any questions, please do not hesitate to call Sabine Aicher at 0761 1514-253. Your contact:Personnel departmentDr. Falk Pharma GmbHLeinenweberstraße 579108 Freiburg im Breisgau #J-18808-Ljbffr