Clinical Operations Director
2 semanas atrás
Job Summary
">This position involves overseeing the clinical operations of a project at a regional or global level. The successful candidate will be responsible for ensuring compliance with study protocols, ICH-GCP, local regulations, and study timelines.
">Main Responsibilities:
">- Oversight of regional CRAs to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations, and study timelines.
- Monitoring support visits (co-monitoring) to aid the site/CRA in satisfactory performance and compliance with standards.
- Support clinical project teams by providing oversight of study deliverables related to other departments (e.g., Data Management, TMF Operations).
- Oversee regional startup and feasibility activities.
- Assist in vendor management activities as required per project.
- Perform review of visit reports for quality, compliance, and appropriate site management.
- Ensure compliance with high-quality and timely project deliverables according to the project requirements and monitoring plan.
- Proactive management of site and country performance (recruitment, data collection, document collection, TMF review) and inform clinical project teams on progress.
- Contribute to financial project management processes as applicable (revenue recognition, site payments, site pass-through expense review).
- Manage/oversee investigator sites including CRA responsibilities on a temporary or permanent basis.
Key Qualifications:
">- Fluent in English (reading, writing, speaking).
- Undergraduate university degree (Bachelors or Honors Bachelors) and 4-6 years' experience plus substantial ongoing job-related training.
- Strong experience with EDC systems, proficiency in MS Office, and excellent written and verbal communication skills.
- Highly effective interpersonal and organizational skills.
- Demonstrate critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC, and Investigator responsibilities.
- Able to handle multiple tasks to meet deadlines in a dynamic environment.
Benefits:
">- Home-based work arrangements.
- Accommodations available for persons with disabilities.
Estimated Salary Range: $80,000 - $120,000 per annum, depending on location and experience.
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