Senior Country Study Start Up Specialist (Sr. CSSUS)

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn , and TikTok . Job Description As Senior Country Study Start Up Specialist, you will proactively drive and execute all start-up and maintenance activities and deliverables for assigned studies and sites in the country. You will be responsible and accountable for on-time, budget, and quality delivery and execution of these activities. You will act as a site start-up expert, providing SME support and mentoring to Country Start Up Specialists through training and change management in adopting new technologies and processes. Note : Sr. CSSUSs will report into their local Country Head but have an operational reporting line to Area and Global SSU Leads. Ensure successful, on-time, and quality execution of start-up and maintenance activities for assigned sites and studies; including central and local IRB / EC sites. Establish activation plans and priorities, including risk assessments and mitigation plans, collaborating with CCOM / COM, Area SSU, CSM Lead, Contract Manager, and Regulatory Affairs. Proactively identify and communicate issues impacting delivery, proposing solutions. Attend regional / area start-up calls, providing input for assigned sites / studies. Collect essential documents from sites, perform quality checks (ALCOA), and complete local submissions, including customization of ICFs and patient materials. Coordinate with Regulatory and CTS on CA submissions and approvals to ensure alignment with site activation requirements. Collaborate with contract managers, CRAs, and CSM Leads to ensure timely activation. Review site and IRB / EC comments on ICFs for approval. Trigger clinical supply shipments, complete IP release activities, and activate sites in IXRS. Track all start-up and maintenance activities in Vault SSU. Maintain local country / site databases and EDLs in Vault. Monitor SSU performance metrics and KPIs, providing updates to relevant leads. Ensure audit / inspection readiness. Ensure compliance with policies, procedures, regulations, and guidelines. Lead process improvement initiatives to enhance site start-up efficiency. Function as a SME in the SSU community, leading training and mentoring of Country Start Up Specialists and driving change management for new technologies and processes. Train and mentor team members as needed. Qualifications Bachelor’s Degree in healthcare or related scientific fields. Minimum 3 years of clinical research experience, with at least 2+ years in study start-up management within the region. Experience interpreting regional regulations and processes. Experience working with IRB / EC sites, including reviewing site / IRB comments and routing for approval. Proficient with Vault SSU, including document processing, IP release, and ICF review. Experience working with remote teams. Strong analytical, critical thinking, and decision-making skills. Excellent interpersonal skills, with the ability to build trust and communicate effectively. Proven success in start-up execution, managing multiple priorities in a fast-paced environment. Experience leading initiatives and projects that support business goals. Knowledge of ICH and GCP guidelines, with operational understanding of regulatory environments. Additional Information AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. We welcome applicants from all backgrounds. For US & Puerto Rico applicants, learn more at https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html and https : / / www.abbvie.com / join-us / reasonable-accommodations.html . #J-18808-Ljbffr