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

Diese Anzeige stammt von Indeed. Originalanzeige ansehen ↗