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TATakeda Pharmaceuticals International AG

Associate Director, Site Start Up and Maintenance(m/w/x)

Zürich
VollzeitVor OrtManagement

Strategic planning for global site regulatory activities in novel specialty pharmaceutical clinical trials. 8+ years in Clinical Operations with 5+ years direct site management oversight required. Mentorship for assigned staff, global regulatory focus.

Anforderungen

  • BS degree or international equivalent in life science
  • Extensive experience (≥ 8 years) in Clinical Operations, Project Management, study start-up, site budgeting and contracting, or trial optimization
  • More than 5 years of direct responsibility in site management and oversight of clinical research studies
  • Expertise in clinical trial regulations and ethics committee submissions
  • Expertise in site contract and budget amendments administration
  • Expertise with leading edge trial optimization vendors, tools, and methods
  • Experience in line management and working in a matrix environment
  • Proficiency with software models and database structures
  • Expertise in principles driving site maintenance strategies including site contract amendments
  • Direct experience in the pharmaceutical industry or related field
  • Ability to demonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operational delivery
  • Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team
  • Ability to explain data and facilitate decision making processes to be data driven

Aufgaben

  • Oversee strategic planning for global site regulatory activities
  • Manage budgeting and contracting maintenance tasks
  • Collaborate with internal and external stakeholders
  • Provide guidance and mentorship to assigned staff
  • Analyze clinical trial intelligence data for resource forecasting
  • Support priority projects through study closure
  • Champion innovative processes and methodologies for site services
  • Partner with CROs and Clinical Operations teams to improve metrics
  • Train Site Start Up and Maintenance Teams on efficient planning
  • Ensure consistent standards across project portfolios
  • Drive implementation of solutions to enhance site maintenance
  • Leverage industry tools for timeline and performance data
  • Monitor adherence to deliverables at country and site levels
  • Lead cross-functional site maintenance teams
  • Serve as a point of escalation for issue resolution
  • Model Takeda’s values in all interactions

Berufserfahrung

  • 8 Jahre

Ausbildung

  • Bachelor-AbschlussODER
  • Master-Abschluss

Sprachen

  • Englischverhandlungssicher
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