
Clinical Project Associate
2 semanas atrás
Our organization provides pharmaceutical, biotechnology, and medical device customers with clinical development, patient access, and technology solutions worldwide. We operate in over 100 countries.
Key Responsibilities- Support the setup, maintenance, and close-out of global or regional projects in clinical trials and post-marketing studies.
- Assist the safety lead in preparing Safety Management Plans, Reconciliation Plans, and other safety-specific plans.
- Support the safety lead in generating study-specific job aids, instructions, trainings, and templates.
- Maintain systems during study startup and ongoing maintenance.
- Support project-specific functional management for assigned projects.
- Reconcile safety databases as needed.
- Prepare and deliver safety presentations to stakeholders.
- Generate monthly status and project-specific reports, ensuring quality and accuracy of metrics/data.
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs) and controlled documents.
- Ensure compliant safety reporting according to US and international regulations.
- Demonstrate role-specific competencies on a consistent basis.
- Embody company values consistently.
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