Als Spezialist in der Verdauungs- und Stoffwechselmedizin und Familienunternehmen mit globaler Vernetzung, setzen wir unseren Fokus auf die Entwicklung und den Vertrieb innovativer Arzneimittel für verschiedene Erkrankungen der Leber, der Gallenwege, des Darms und der Speiseröhre, um das Leben von Menschen zu verbessern. Wir glauben daran, dass wir nur gemeinsam medizinischen Fortschritt erreichen können. Daher suchen wir:
Clinical Project Manager Early Clinical Research - Pharmacology (m/f/d)
Partially working from home possible
Ihre Aufgaben
- 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)
Ihre Qualifikation
- 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
Ihre Vorteile
- 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