Country Study Start Up Specialist

🔥 51 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 10%

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Drive and execute start-up and maintenance activities and deliverables for assigned studies and sites • Ensure timely, high-quality execution of start-up and maintenance activities • Act as a site start-up expert and provide subject matter expert support • Establish country/site activation plans, priorities, risk assessments, and mitigation plans • Identify and communicate delivery issues and proposed solutions • Attend regional/area start-up calls and provide input • Collect essential site documents and complete ALCOA quality checks • Compile and submit ethics and local regulatory submissions, including customized ICFs, patient-facing materials, and safety reporting • Coordinate with Regulatory and CMS on Competent Authority submissions and approvals • Collaborate with contract managers, CRAs, and CSM leads to achieve timely site activation • Review site and IRB/EC comments on ICFs and route them for functional approval • Facilitate clinical supply shipments • Complete investigational product release activities and trigger IP shipments • Issue site green-light letters and activate sites in IXRS • Track start-up and maintenance activities in Vault Study Start-Up • Maintain country/site intelligence databases and Expected Document Lists in Vault • Maintain performance metrics and KPIs for assigned sites and studies • Provide start-up updates and metrics to operations and SSU/CSM leads • Ensure audit and inspection readiness • Ensure compliance with corporate and divisional policies, worldwide regulations, and guidelines • Lead process improvement initiatives to increase site start-up efficiency • Serve as an SSU subject matter expert and lead training and mentoring of Country Start-Up Specialists • Drive change management for new technologies and processes • Act as area lead for single-country studies

🎯 Requirements

• Bachelor's degree in Health Care or Science highly preferred • Minimum of three years of clinical research experience • Preferably more than two years of study start-up management experience for the designated region • Hands-on experience interpreting regional clinical research regulations and processes • Experience working with central and local IRB/EC sites, including reviewing site and IRB/EC comments on ICFs and routing for approval • Experience with Vault SSU for essential document processing, IP release, and ICF IRB/EC review • Experience working with remote/virtual teams • Strong analytical and critical thinking skills • Ability to evaluate complex issues from multiple perspectives and drive decision-making • Strong interpersonal skills and ability to build trust and communicate with clarity, flexibility, and adaptability • Demonstrated successful start-up execution and ability to manage multiple priorities in a fast-paced environment • Demonstrated experience driving and leading successful initiatives, special projects, and business-supporting activities • Working knowledge of ICH and GCP guidelines • Operational understanding of the country's regulatory environment • Must be available to attend the head office in St-Laurent, Quebec, occasionally for training • French and English language proficiency, oral and written • Advanced knowledge of English / fluency in English is an essential requirement

🏖️ Benefits

• Innovative work culture • Professional development • Paid time off: vacation, holidays, personal days, and volunteer days • Employee stock purchase • Wellness spending account • Flexible health insurance • Retirement savings programs • Bonus plan • Remote work arrangement • Equal opportunity employer committed to integrity, innovation, transforming lives, and serving the community

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