Clinical Studies Specialist II
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The Opportunity
Description
We're looking for a Clinical Studies Specialist II, working in Pharmaceuticals and Medical Products industry in Lake Bluff, Illinois, United States.- Manages and ensures inspection readiness of Trial Master File (TMF)
- Actively studies team member for assigned studies.
- Ensures real-time inspection readiness of TMF by collaborating with Artifact Owners, reviewing assigned TMFs to ensure accuracy and completeness, and tracking and reporting status to study team(s).
- Develops and updates study-specific TMF structure documentation.
- Provides support for audits / inspections.
- Collaborates with Clinical Documentation Center Operations colleagues.
- Complies with GCP, AbbVie SOPs and functional area processes.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Bachelor degree or international equivalent is required
- 4 year degree required
- Experience Clinical Research Coordinator, CRA regulatory, Doc Management
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
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