Clinical Trial Manager

hace 1 semana


Madrid, Madrid, España Icon A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Trial Manager to join our team at ICON. As a Clinical Trial Manager, you will be responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.

The successful candidate will have a minimum of 2 years of experience as a Lead CRA/LTM/CTM and will be responsible for country do-ability and site feasibility assessment in conjunction with CTA, CRA and PM. They will also implement any local criteria for site selection and ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report.

The Clinical Trial Manager will collaborate with the CPL, PM, local management/Country Head and Protocol Owner to select final site list and contribute input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiate development of these plans for a single country trial.

Key Responsibilities:

  • Lead and coordinate local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations.
  • Develop local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
  • Ensure that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
  • Maintain and update trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints).
  • Use study tools and management reports available to analyze trial progress.
  • Monitor country progress and initiate corrective and preventive actions when the trial deviates from plans and communicate study progress and issues to study management teams.

Requirements:

  • A minimum of a BA/BS degree is required.
  • A degree in a health or science related field is preferred.
  • Experience as Lead CRA/LTM/CTM of at least 2 years.
  • Experience in submissions.
  • Specific therapeutic area experience may be required depending on the position.
  • Should have basic understanding of the drug development process including ICH/GCP and local regulatory requirements.
  • Solid communication and computer skills required.
  • Proficient in speaking and writing the country language and English language.

We offer a competitive salary and a range of benefits including annual leave entitlements, health insurance, retirement planning, and flexible country-specific optional benefits.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation.


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