Job Description
Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process?
Our Client, a global leading Biotech company is looking for a Senior Clinical Specialist/Senior Clinical Research Associate.
Tasks
1. Manage all aspects of clinical studies, including planning, initiation, monitoring, and close-out, ensuring compliance with ICH-GCP, GVP, and regulatory requirements.
2. Conduct site evaluation and setup for SCENESSE® commercial distribution, including training and initiation activities.
3. Maintain ongoing communication with sites involved in commercial distribution and clinical trials to ensure smooth operations.
4. Collect and maintain essential study documentation in line with applicable regulations and quality standards.
5. Monitor data collection processes and oversee pharmacovigilance and safety reporting at study sites.
6. Prepare and review site visit reports, ensuring accuracy and regulatory compliance.
7. Manage site-related processes, including payment tracking and reconciliation.
8. Track study progress, perform quality control checks, and provide timely updates to internal teams.
9. Participate in investigator meetings, internal team meetings, and relevant industry conferences.
10. Assist with audits and inspections, ensuring readiness and adherence ...