Country Study Start Up Specialist

About the role

AbbVie is looking for a proactive Country Study Start Up Specialist to own the activities that move clinical studies from planning through to site activation in Australia. Working across studies and sites, the role coordinates ethics submissions, documentation, informed consent materials and site activation requirements, partnering with Clinical Operations, Regulatory Affairs, Contracts, CRAs and regional and global Study Start Up teams. The position suits someone with clinical research, study start-up, site activation or regulatory submissions experience.

Key responsibilities

• Ensure on-time, quality execution of start-up and maintenance activities for assigned sites and studies, mainly central IRB/EC sites
• Establish country/site activation plans and priorities, including risk assessment and mitigation plans, with CCOM/COM, Area SSU and CSM Lead, Contract Manager and CTS/Regulatory Affairs
• Identify and communicate delivery issues with proposed solutions, and attend regional/area start-up calls
• Collect essential documents from sites and complete quality checks (ALCOA)
• Compile and submit ethics and other local submissions, customise ICFs and patient-facing materials, and coordinate with Regulatory and CTS on CA submission and approval status
• Review site and IRB/EC comments on ICFs and route them for approval, then trigger clinical supply shipments and IP release
• Issue the site green light letter, activate sites in IXRS, track activities in Vault SSU, maintain the 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

Required profile

• Bachelor's degree in a health care or scientific field highly preferred, or equivalent years of experience
• At least 1-2 years of clinical research experience, preferably 1+ year of study start-up management experience for the region
• Experience working with remote/virtual teams
• Successful execution in start-up and ability to manage multiple priorities in a fast-paced environment

Required skills

• Working knowledge of ICH and GCP guidelines and understanding of the country's regulatory environment
• Analytical and critical thinking, strong interpersonal and communication skills