The role purpose: The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.

Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads.

Primary RESPONSIBILITIES include but not limited to:

• Ensuring successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites.
• Establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs.
• Proactively identifying and communicating issues impacting delivery and providing proposed solutions.
• Attending regional/area start up calls and providing input for assigned sites/studies.
• Collection of essential documents from sites and completing quality check (ALCOA).
• Compiling and submitting ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting.
• Coordinating with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements.
• Collaborating with contract manager, CRA, Area CSM Lead as required to assure timely site activation.
• Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas.
• Triggering clinical supply shipments.
• Completing IP release activities and triggering IP shipment.
• Issuing site green light letter and activating sites in IXRS.
• Tracking all start up and maintenance related activities in Vault SSU as appropriate.
• Maintaining local country and site intelligence database and EDLs in Vault.
• Maintaining SSU performance metrics and KPIs for assigned sites/studies.
• Providing start up updates and metrics to CCOM/COM and Area SSU and CSM Leads
• Ensuring audit/inspection readiness.
• Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
• Participating in process improvement initiatives as required.

• Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required.
• A minimum of 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 and 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.
• Very good verbal and written communication in both English and Polish.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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