Aufgaben

  • Trial Leadership: Act as a core participant within the Clinical Trial Team and maintain a strong collaborative relationship with the Clinical Trial Physician
  • Scientific Oversight: Manage the scientific planning, implementation, data oversight, and reporting of Phase II and III global trials
  • Document Authoring: Lead or contribute to the authoring of essential study documents, including clinical protocols, Investigator’s Brochures, Informed Consent Forms (ICFs), and Clinical Study Reports (CSR)
  • Cross-functional Input: Provide scientific expertise for the development of Case Report Forms (CRFs), Statistical Analysis Plans (SAPs), and monitoring guidelines
  • Data Monitoring: Perform continuous clinical data reviews and support medical monitoring activities during the trial conduct
  • Committee Management: Oversee the setup and coordination of study-specific committees (e.g., IDMC or Steering Committees)
  • Regulatory Support: Provide scientific input for responses to Health Authorities and Ethics Committees (IRB/EC)
  • External Engagement: Participate in high-level scientific discussions with external experts and investigators
  • Training: Educate internal study teams and stakeholders on the scientific objectives and nuances of the trial

Qualifikationen

  • Advanced academic degree (PhD, PharmD, MSc, or equivalent) in life sciences or a health-related field
  • At least 2 years of professional experience in clinical drug development within a pharmaceutical company or a CRO
  • Previous experience with Phase II and III clinical trials is highly desirable
  • Fluency in English, both written and spoken
  • Excellent analytical, organizational, and problem-solving abilities
  • Proven capability to manage multiple priorities effectively under tight deadlines
  • Strong communication and stakeholder management skills
  • A proactive, results-oriented, and quality-focused mindset
  • Ability to work both independently and as a collaborative member of a global matrix team