Clinical Research Manager

hace 4 semanas

Zaragoza, Zaragoza, España Icon A tiempo completo

Job Summary

Clinical Research Manager at Icon

As a Clinical Research Manager at Icon, 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 be the primary point of contact at a country level for assigned studies, responsible for country do-ability and site feasibility assessment in conjunction with CTA, CRA, and PM. They will implement any local criteria for site selection, 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 Research Manager will recommend suitable sites for selection to participate in trial, 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.
  • Lead local project planning activities to meet recruitment targets and deliver high-quality data on time and within study budget.
  • 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.
  • May submit requests for vendor services and may support vendor selection.
  • May lead negotiation of trial site contracts and budgets.
  • Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered within budget.
  • Adheres to finance reporting deliverables and timelines.
  • Attends/participates in Investigator Meetings as needed.
  • May schedule and conduct a local/country investigator meeting.
  • Conducts local trial team meetings and provides or facilitates CRA training when needed (e.g., implementation of study amendment and changes in study-related processes).
  • Reviews and approves Monitoring Visit Reports submitted by CRA; identifies issues and/or trends across a trial project and escalates deviation issues to the PM and FM as needed.
  • Reviews and approves site and local vendor invoices as required.

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