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 Clinical Specialist/Junior Clinical Research Associate.
Tasks
1. Conduct site evaluation and setup for SCENESSE® commercial distribution, including dosing training in collaboration with the Clinical Project Manager or designee
2. Maintain communication with sites involved in SCENESSE® commercial distribution and potential clinical trial sites
3. Collect essential documents in compliance with ICH-GCP E6 (R2) and applicable regulations
4. Monitor data collection and pharmacovigilance/safety reporting at post-authorisation study sites
5. Manage site setup, initiation, monitoring, and close-out for clinical and post-authorisation studies as needed
6. Oversee site operations including supply management and payment processes
7. Track study and clinical trial status and provide progress updates to the team
8. Prepare and submit documentation to EC/IRB and regulatory authorities
9. Participate in investigator meetings, and relevant conferences
10. Contribute to newsletters and other communications as directed by the Clinical Project Manager or designee
11. Assist with audits as required
12. Support p...