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vendor management protocol cro phi hipaa📋 Description
- Manage the execution of all aspects of complex clinical studies to meet timelines, cost and quality metrics.
- Oversee vendor/CRO selection and ongoing management to ensure compliance and delivery within budget and timeline.
- Manage study contracting, budgeting, forecasting, accruals and payments for all vendors and sites.
- Lead protocol/informed consent prep, investigator selection, training materials, monitoring plans, CRFs, TMF maintenance and amendments.
- Collaborate with Clinical Data Management to ensure correct CRF content and study reports; design data listings.
🎯 Requirements
- Bachelor’s degree in life sciences; advanced degree preferred.
- 8+ years clinical research experience; at least 4 years leading trials.
- 4-7 years supporting clinical trials in a regulated environment.
- Experience managing CROs is preferred.
- Knowledge of Clinical Trial SOPs, FDA regulations and ICH-GCPs.
- Proficiency in MS Word, Excel and PowerPoint.
🎁 Benefits
- Competitive benefits package including medical, dental, vision, life and disability.
- Free testing for employees and immediate family; fertility care benefits.
- Pregnancy and baby bonding leave; 401k and commuter benefits.
- Employee referral program.
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