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AbbVie

Country Study Start Up Specialist

AbbVie

. Drive and execute start-up and maintenance activities and deliverables for assigned studies and sites .

Posted 11/4/2026full-timeRemote • Montreal • CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical study start-up and maintenance activities, ensuring compliance with ICH and GCP guidelines while effectively managing multiple priorities. Proficient in regulatory submissions and site activation processes, with strong analytical and interpersonal skills to facilitate collaboration and communication.

Highest-signal resume keywords
Clinical Research ExperienceStudy Start-Up ManagementVault SSU ProficiencyRegulatory SubmissionsBilingual Proficiency in French and English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Clinical Study Start-UpRegulatory ComplianceDocument ProcessingIP Release ActivitiesRisk AssessmentKPI TrackingALCOA Quality ChecksEthics SubmissionSite Activation PlanningProcess Improvement Initiatives
Soft Skills
Analytical ThinkingInterpersonal SkillsDecision-MakingCommunication SkillsAdaptability
Tools & Technologies
Vault Study Start-UpIXRSCMSIRB/EC Review
Industry Keywords
ICH GuidelinesGCP GuidelinesClinical Research RegulationsSite ActivationCountry Regulatory Environment

Tech Stack

Tools & technologies
Vault

About the role

Key responsibilities & impact
  • 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

What you’ll need
  • 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

Comp & perks
  • 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