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

Your tasks Strategic planning, execution, and oversight of international phase I clinicals 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 (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 desire Strong organizational skills, analytical thinking, and enjoyment of systematic work Flexibility and resilience Strong communication skills Independent and team-oriented working style

Your 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 If you have any questions, please do not hesitate to contact Sabine Aicher at personal@drfalkpharma.de or call 0761 1514-253. We look forward to receiving your application via our online portal.