Associate, Study Management II
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Job Description
Clinical study management associate supporting immunology trial execution, documentation, vendors, and study teams. AbbVie develops innovative medicines addressing serious health challenges.
Responsibilities:
- Execute one or more elements of clinical studies in compliance with ICH/GCP, global regulations, and AbbVie policies and procedures
- Support the Study Project Manager in leading the cross-functional study team
- Prepare Clinical Study Team meeting agendas and minutes
- Provide regular study-status updates to the cross-functional team and stakeholders and keep the CTMS up to date
- Support development of clinical study blueprints/protocols and associated systems and documents, including informed consent forms, eCRFs, IRT, and CSR
- Support vendor selection, scope development, management, and oversight in compliance with AbbVie processes and applicable regulations
- Generate study-related training for study teams, study sites, and vendors
- Proactively identify, resolve, and/or escalate study-related issues
- Participate in process improvement initiatives
Requirements:
- Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field
- Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable
- Two years of Pharma-related/clinical research related experience or professional equivalent desired
- Analytical and critical thinking skills
- Good communication skills
Benefits:
- Equal opportunity employer
- Committed to operating with integrity, driving innovation, transforming lives and serving the community
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