Analyst II, Study Start Up Operations

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AbbVie

πŸ“Remote - United States

Summary

Join AbbVie as a Clinical Development Operations Subject Matter Expert, providing support for clinical trial-related systems, particularly focusing on SSU activities. You will lead the maintenance of the Vault Clinical system, address stakeholder inquiries, analyze requests, and conduct cross-functional meetings. Responsibilities include creating reports and dashboards, updating work instructions and SOPs, leading system integrations, and supporting new staff onboarding. This global remote position requires a Bachelor's degree, 5+ years of relevant experience, and proficiency with Veeva Vault Clinical. AbbVie offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and a 401(k).

Requirements

  • Bachelor's degree required with min. 5 years relevant industry experience or equivalent experience
  • Proficient use of electronic systems
  • Three years experience using Veeva Vault Clinical application management
  • Proficient knowledge of clinical trial management systems and procedures
  • Experience in clinical trial business process
  • Strong communication skills (oral and written) and proven effective, collaborative interactions with colleagues
  • Strong Interpersonal skills with the ability to communicate with clarity, flexibility, and adaptability to changing requirements
  • Experience working with remote/virtual teams
  • Proven analytical, critical thinking and organizational skills
  • Proven effective, collaborative interactions with colleagues. Proactive and positive team player
  • Operates independently with the ability to manage several projects at the same time
  • Proficient knowledge of clinical documentation business procedures
  • Proficient use of Excel

Responsibilities

  • Lead business level maintenance of Vault Clinical system
  • Triages and provides answers to stakeholder system-related questions
  • Analyze stakeholder requests and suggestions
  • Lead stakeholder SME and cross-functional meetings and maintains a positive working relationship with internal/external customers and colleagues
  • Proactively identify and communicate issues that could affect the quality of data, systems or processes providing proposed or developing alternative solutions, to ensure corrective action is implemented as appropriate
  • Create, run, and analyze reports and dashboards within Vault Clinical. Produce metrics to socialize
  • Lead creation or updates to Work Instructions, Job Aids, and SOPs related to Vault Clinical and leads process trainings
  • Provides suggestions and feedback regarding issues or potential improvements and leads functional area continuous improvement projects and/or work streams
  • Lead system integrations with VAULT Clinical
  • Operates independently, leads as a Subject Matter Expert
  • Partners with functional areas representatives and IT
  • Supports Management with onboarding process of new staff
  • Complies with GCP, AbbVie SOPs and functional area processes

Preferred Qualifications

Experience with SmartSheet

Benefits

  • Paid time off (vacation, holidays, sick)
  • Medical/dental/vision insurance
  • 401(k)
  • Short-term incentive programs
  • This is a Global Remote position

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