Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Global Clinical Trials Manager (CNS or Rheumatoide Arthritis) (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Start-up, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations
- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables
- Develops and manages clinical study budgets Develops and manages clinical study budgets
- Designs drug assumption and supply chain process in partnership with Drug Supply Coordinator
- Ensures that safety reporting is established and maintained for the duration of the study and that reporting timelines are met
- Primary contact with CRO and affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action
- Performs ongoing vendor management (e.g., CROs, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution
- Develops and executes appropriate site and CRO/vendor audit and quality plans
Ihre Qualifikation
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
Skills:
- Clinical Project Management
- CRA
- Product Management Pharma
- Project Management Pharma