Country Study Start Up Specialist

hace 1 mes

Xico, México Abbvie A tiempo completo

**Job Summary**:

Abbvie is seeking a highly skilled Country Study Start Up Specialist to proactively drive and execute all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.

**Key Responsibilities**:

  • Ensure successful and on-time execution of start-up and maintenance activities for assigned sites and studies.
  • Establish country/site activation plans and priorities, including risk assessment and mitigation plans with local country teams.
  • Proactively identify and communicate issues impacting delivery and provide proposed solutions.
  • Attend regional/area start-up calls and provide input for assigned sites/studies.
  • Collect essential documents from sites and complete quality checks.
  • Compile and submit ethics and other required local submissions, including customization of ICFs and patient-facing materials.
  • Coordinate with regulatory and clinical teams on CA submission and approval status.
  • Collaborate with contract managers, CRAs, and other stakeholders to ensure timely site activation.
  • Review site and/or IRB/EC comments on ICFs and route for approval by required functional areas.
  • Trigger clinical supply shipments and complete IP release activities.
  • Issue site green light letters and activate sites in IXRS.
  • Track all start-up and maintenance related activities in Vault SSU.
  • Maintain local country and site intelligence databases and EDLs in Vault.
  • Maintain SSU performance metrics and KPIs for assigned sites/studies.
  • Provide start-up updates and metrics to local country teams and area SSU leads.
  • Ensure audit/inspection readiness and compliance with corporate and divisional policies and procedures.

**Requirements**:

  • Bachelor's degree in a health care or scientific field (or equivalent years of experience).
  • Minimum 1-2 years of clinical research experience and preferably 1+ years of study start-up management experience for the designated region.
  • Experience working with remote/virtual teams.
  • Strong analytical and critical thinking skills, with the ability to evaluate complex issues from multiple perspectives.
  • Strong interpersonal skills, with the ability to build trust and communicate with clarity, flexibility, and adaptability to changing requirements.
  • Demonstration of successful execution, preferably in start-up, and aptitude for managing multiple priorities in a fast-paced environment.
  • Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.

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