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.
