Senior Specialist, Country Study Start Up

About the role

AbbVie is looking for an experienced Senior Specialist, Country Study Start Up, based in Sydney, to take a leading role in how clinical studies move from planning to activation across Australia. The role goes beyond the transactional elements of study start-up: you will own and drive start-up and maintenance activities across assigned studies and sites, bring together Clinical Operations, Regulatory Affairs, Contracts and study teams, and mentor colleagues and lead process improvements.

Key responsibilities

• Ensure on-time, quality execution of start-up and maintenance for assigned sites and studies, including central and local IRB/EC sites
• Establish activation plans and priorities, including risk assessment and mitigation, with CCOM/COM, Area SSU, CSM Lead, Contract Manager and CTS/Regulatory Affairs
• Identify and communicate delivery issues with proposed solutions, attend regional/area start-up calls and provide input for assigned sites
• Collect essential documents from sites, complete quality checks (ALCOA), and compile and submit ethics and local submissions, customising ICFs, patient-facing materials and safety reports
• Coordinate with Regulatory and CTS on CA submission and approval, and with the contract manager and CRA to ensure timely site activation
• Review site and IRB/EC comments on ICFs and route them for approval, trigger clinical supply shipments, complete IP release and issue the site green light letter
• Track start-up and maintenance activities in Vault SSU, maintain the local country and site intelligence database and EDLs, and report start-up metrics to leadership
• Prepare for audits and inspections, comply with corporate policies and worldwide regulations, and report adverse events within 24 hours
• Lead process improvement initiatives, train and mentor Country Start Up Specialists, and act as area lead for single-country studies

Required profile

• Bachelor's degree (healthcare or scientific field) highly preferred, or equivalent years of experience
• At least 3 years of clinical research experience, preferably 2+ years of study start-up management in the region
• Hands-on experience interpreting regional clinical research regulations and working with central and local IRB/EC sites
• Experience working with remote/virtual teams
• Successful track record of start-up execution and managing multiple priorities in a fast-paced environment

Required skills

• Adept use of Vault SSU for document processing, IP release and ICF/IRB/EC review
• Working knowledge of ICH and GCP guidelines and the country's regulatory environment
• Analytical thinking, strong communication and mentoring abilities