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Clinical Trials Specialist
3 weeks ago
Job Summary
We are seeking a motivated and detail-oriented Clinical Trials Specialist to join our team. In this role, you will be responsible for managing and reviewing adverse events, product quality complaints, and medical information.
Key Responsibilities
- Manage and review expeditable adverse events, product quality complaints, and medical information.
- Submit reports to clients and regulatory agencies within agreed timelines.
- Assist in process reviews and measure/monitor audit readiness.
- Coordinate client or external audits of assigned projects.
- Design and track training schedules and materials for new hires and existing team members.
- Contribute to quality error discussions and process improvements.
- Assist in developing Quality Management Plans for assigned projects.
- Support clients during regulatory inspections with the project team.
- Perform and review data analysis to suggest and drive process improvements.
- Track various types of information and metrics, conduct ongoing QC of defined process steps, and reconcile data from multiple sources.
- Respond to medical information queries, product quality complaints, and general queries received via telephone, email, fax, etc.
- Review recorded information and execute drug safety data management processes.
- Guide safety associates in managing voice calls as required.
- Review and drive strategies for process improvement/excellence.
- Review safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging Reports, Investigator Brochures, Clinical Study Reports, etc.
Why Join Us?
- Embrace a collaborative workspace that nurtures personal growth.
- Make a meaningful global impact in clinical development.
- Join an exceptional team dedicated to innovation and excellence.
