58 days ago on ctcon.ch

International Trial Leader

CTC Clinical Trial Consulting AG

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  • Employment type
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 Please refer to JobSuchmaschine in your application

International Trial Leader

Reference Number: 895127-W
Type of placement: Permanent
Location: Switzerland, North West

Introduction:

Main Responsibilities:

  • Leading and providing direction to the global cross-functional team to ensure all trial output from protocol development to final clinical study report are delivered on time, within budget, and with highest achievable quality
  • Developing, updating, and ensuring adherence to agreed upon global trial budget
  • Leading  team meetings and ensure timely follow up of agreed upon actions
  • Ensuring adequate trial resources in personnel and material cross-functionally
  • Creating, maintaining, and updating the Clinical Trial Plan
  • Coordinating the development of trial-related core documents, such as the protocol, site guidelines, data management plan, statistical analysis plan, and clinical study report
  • Coordinating the development of specifications for external service providers in collaboration with global departments and ensure appropriate quality control of deliverables
  • Leading trial-related external meetings, e.g. Investigator meetings
  • Providing regular trial status updates (including critical issues and key performance indicators) and resolving issues at a team level in a proactive and timely fashion
  • Escalating unresolved issues
  • Coordinating pre-audit activities ensuring satisfactory outcome
  • Implementing best practices and lessons learned and share outcome with the teams
  • Assuming responsibility for other project or trial-related duties as assigned

Qualifications and Experience:

  • Master’s degree or equivalent university education/degree in life sciences or healthcare
  • Minimum of 7 years relevant experience in clinical development and clinical trial management
  • Demonstrated expertise in global clinical research and development and project management
  • Advanced knowledge of International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and other relevant clinical trial regulations
  • Demonstrated experience and leadership skills
  • Experience in executing a wide range of clinical trial activities
  • Experience selecting and managing external service providers
  • Good understanding of clinical trial budget/resource forecasting and management
  • Ability and willingness to travel internationally
  • Fluent in English; fluency in other languages is advantageous
  • Relevant working/residency permit or Swiss/EU-Citizenship required