Athletics fundraising coordinator advancing University of Alberta Golden Bears and Pandas sports programs. Managing donor stewardship, alumni relations, fundraising initiatives, events and data - driven operations.
About the role
- Clinical study start-up specialist coordinating regulatory, document, and site activation activities for AbbVie’s innovative medicines. Supporting Canadian clinical trial delivery, compliance, and process improvement.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Tech skills
Location requirements
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