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

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

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.

Contact

HR department Dr. Falk Pharma GmbH Leinenweberstraße 5
79108 Freiburg im Breisgau