Clinical Project Manager Early Clinical Research - Pharmacology (m/f/d)

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:

• #### Your tasks
• 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)

• #### Your qualification
• Completed medical, scientific, or pharmaceutical degree
• Several years of professional experience in the pharmaceutical industry in clinical development and clinical study project management, ideally in Phase I
• Experience in clinical pharmacology (pharmacokinetics, pharmacodynamics)
• Solid knowledge of regulatory requirements for conducting clinical trials
• Excellent knowledge of MS Office applications
• Excellent written and spoken English skills, basic german skills desirable
• Strong organizational skills, analytical thinking, and enjoyment of systematic work
• Flexibility and resilience
• Strong communication skills
• Independent and team-oriented working style