Analyst II, Study Start Up Operations
AbbVie
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