Senior Clinical Trial Operations Manager

hace 21 horas


Madrid, Madrid, España Icon Strategic Solutions A tiempo completo

Job Summary: We are seeking a highly experienced Senior Clinical Trial Operations Manager to join our team at Icon Strategic Solutions. The ideal candidate will have a strong background in clinical research and a proven track record of delivering high-quality results.

About the Role: As a Senior Clinical Trial Operations Manager, you will be responsible for overseeing the day-to-day operations of clinical trials within your assigned country or region. This includes managing local trial teams, coordinating with cross-functional groups, and ensuring compliance with regulatory requirements.

Main Responsibilities:

  • Manage local trial teams to ensure timely and efficient delivery of clinical trials
  • Coordinate with cross-functional groups, including research sites, vendors, and internal stakeholders
  • Ensure compliance with regulatory requirements, including GCP, SOPs, and applicable laws
  • Develop and implement process improvements to enhance operational efficiency and quality
  • Contribute to the development of trial plans, budget forecasts, and risk management strategies
  • Maintain accurate and up-to-date records and reports, including CTMS, eTMF, and other relevant systems

Key Requirements:

  • 5+ years of experience in clinical research, with a focus on trial operations and management
  • Proven track record of delivering high-quality results and improving operational efficiency
  • Strong knowledge of GCP, SOPs, and regulatory requirements
  • Excellent communication and project management skills
  • Ability to work independently and collaboratively as part of a team

What You Will Do:

  1. Conduct country do-ability and site feasibility assessments in conjunction with CTA, CRA, and PM
  2. Implement local criteria for site selection and ensure consistent conduct of pre-trial assessment visits
  3. Recommend suitable sites for selection to participate in trials
  4. Collaborate with CPL, PM, local management/Country Head, and Protocol Owner to select final site lists
  5. Contribute input to Trial Plans, Safety Monitoring Plans, Filing and Archiving Plans, and Investigational Product documents at a country level or initiate development of these plans for single-country trials
  6. Lead and coordinate local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI), and applicable regulations
  7. Monitor country progress and initiate corrective and preventive actions when the trial deviates from plans

Salary: $120,000 - $150,000 per annum

Benefits: Comprehensive benefits package, including health insurance, retirement plan, and paid time off



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