Senior Clinical Trial Leader (m/f)

Beschreibung

• Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations
• Drives protocol development process
• Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form, and other key protocol/program documents and activities
• Leads multiple cross-functional trial teams through start-up activities including study/site budgets and contracts, global geographic deployment (country/site identification, feasibility, selection), and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting
• Leads the execution of clinical phases of assigned global programs across all phases (Phase 1-4) including post-marketing commitments
• Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies, and promptly responding to action items
• Develops and leads the presentation on trial status to governance bodies and other relevant committees for deviations from budget and timelines as needed, highlighting issues and risks
• Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning
• Drives oversight of CROs and vendor management at trial level according to the applicable partnership model
• Acts as functional lead for process improvement initiatives
• Understanding of trial feasibility elements
• Understanding of regulatory requirements across countries

• Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) preferred or equivalent
• Proven experience as Clinical Trial Leader for global, large phase III studies with own accountability and responsibility
• Strong Project Management/ Leadership/ Budget Management Skills and experience within recent employments
• Indication knowledge: mandatory Oncology, preferred NDD and Endocrinology
• Requires substantial professional experience
• Requires very senior knowledge and experience in own discipline and beyond to supplement formal knowledge in order to apply principles and concepts of own discipline in resolving issues as they arrive
• Deep experience in clinical research in CRO or a Pharmaceutical or Biotechnology Industry environment and in clinical trial management
• Extensive experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report
• Proven track record of having successfully led one or more multinational trials