AbbVie is looking for a motivated and organized professional to join as a Country Study Start Up Specialist. We are looking for someone with a proactive mindset to help coordinate start-up activities, support the successful delivery of study and site activation processes.

This is a highly collaborative role, requiring close interaction with internal stakeholders and external partners to ensure timely delivery, quality execution, and strong operational follow-up.

The Country Study Start Up Specialist (CSSUS) proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.

Responsibilities

• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies. Establish the country/site activation plans and priorities including risk assessment and mitigation plans.
• Proactively identify and communicate issues impacting delivery and providing proposed solutions. Attend regional/area start up calls and providing input for assigned sites/studies. Collection of essential documents from sites and completing quality check.
• Compile and submit ethics and other required local submissions including customization of Informed Consent Forms (ICFs), patient facing materials and safety reporting. Coordinate with Regulatory Competent Authority submission and approval status to assure alignment with other site activation requirements.
• Collaborate with Contract manager, Clinical Research Associate, Study Start up Lead and Site Management Lead as required to assure timely site activation. Reviewing site and/or Institutional Review Board/Ethics Committee comments on ICFs and routing for approval by required functional areas. Trigger clinical supply shipments.
• Issue site green light letter and activating sites. Track all start up and maintenance related activities as appropriate. Maintain local country and site intelligence database.
• Maintain Study Start-Up performance metrics and KPIs for assigned sites/studies. Provide start up updates and metrics. Ensure audit/inspection readiness.
• As CSSUS you are responsible for managing your own projects, ensure efficient planning and accelerating study start-up
• Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
• Participate in process improvement initiatives as required.