Clinical Global Program Leader

Inactive

Reference Number: 895603
Type of placement: Permanent, Permanent
Location: Switzerland, North West

Introduction:

Main Responsibilities:

  • Oversees a therapeutic area to ensure early operational input into planned Phase 1b to Phase 3 trials
  • Creates and monitors high-level project plans, including key milestones and timelines, consistent with the overall program strategy
  • Creates a forecast for resources on clinical trials, and monitors the workload of on-going projects, escalating any substantial variations
  • Consults with necessary stakeholders to ensure proper resource planning and outsourcing strategy for the planned clinical trials.
  • Lead and provide direction to the global cross functional clinical trial team (CTT)
  • Develops, updates, and ensures adherence to approved global trial budget, including grant management and Investigator fees
  • Coordinate the development of trial-related core documents, such as the protocol, site guidelines, data management plan, statistical analysis plan, and clinical study report
  • Contribute to program and trial investigational and non-investigational medical product (IMP and NIMP) planning and track supply usage, escalating any substantial variations
  • In collaboration with program and study teams, develop high-level country and site strategy plan for clinical trials, and validate final choices to ensure optimal trial conduct
  • Represent the program at LCT
  • Chair CTT meetings and ensure timely follow up of agreed upon actions
  • Lead Investigator Meetings
  • Provide regular trial status updates (including critical issues and key performance indicators) and resolve issues at the CTT level in a proactive and timely fashion
  • Escalate unresolved issues as appropriate
  • Provide input for surveys and audit reports
  • Ensure implementation and supervise respective corrective and preventive actions on trial level (CAPAs)

Qualifications and Experience:

  • Advanced University degree or equivalent education/degree in life sciences or healthcare
  • At least 10 years of relevant experience in clinical research in a pharmaceutical and/or Contract Research Organization (CRO) environment, with a good scientific and operational understanding of Phase 1 to 3 clinical trials
  • Solid experience in all aspects of clinical trial planning and start-up (including budget & resource planning) and in executing a wide range of clinical trial activities, from set-up through to final clinical study report
  • Demonstrated expertise in clinical development and project management (including risk management and contingency planning)
  • Excellent understanding of the roles and responsibilities of all relevant functions involved in a clinical trial and program (e.g. Biostatistics, Data Management, Regulatory, Drug Safety, external service providers, etc.)
  • Demonstrated experience and leadership skills
  • Strong experience working in global cross-functional (matrix) and multicultural teams
  • Good understanding of clinical trial budget/resource forecasting and management
  • Proven ability to mentor and train colleagues in functional knowledge and skills
  • Able to develop an understanding of the scientific background of trial protocols
  • Well-versed in International Council for Harmonization - Good Clinical Practice (ICH-GCP) guidelines and other relevant clinical trial regulations
  • Fluent in English; fluency in other languages is advantageous
  • Ability and willingness to travel internationally
  • Experience in managing complex clinical trials (e.g., large Phase III trials)
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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