Related skills
budget management edc site management tmf ich-gcpπ Description
- Oversee operational execution of clinical studies from concept to completion.
- Work with Clinical Trial Managers to meet timelines, costs, and quality metrics.
- Develop study documents (protocols, consents) and monitoring plans.
- Manage contracting, budgeting, invoicing for vendors and sites.
- Support CRF design and EDC testing; assist TMF content.
- Monitor study progress and ensure SOPs and GCP compliance.
π― Requirements
- BA/BS in life sciences or related field.
- Minimum 4 years' experience in clinical studies.
- Experience with clinical EDC systems.
- Familiarity with TMF structure and document management.
- Knowledge of SOPs, ICH-GCP, and FDA regulations.
- Strong MS Word, Excel, PowerPoint skills; ability to lead projects.
π Benefits
- Pay range: $99,400β$124,200 USD (Remote USA).
- Competitive benefits including medical, dental, vision, life, and disability.
- 401(k), commuter benefits, and fertility care coverage.
- Generous leave and employee referral program.
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