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
* Conduct site evaluation and setup for SCENESSE® commercial distribution, including dosing training in collaboration with the Clinical Project Manager or designee
* Maintain communication with sites involved in SCENESSE® commercial distribution and potential clinical trial sites
* Collect essential documents in compliance with ICH-GCP E6 (R2) and applicable regulations
* Monitor data collection and pharmacovigilance/safety reporting at post-authorisation study sites
* Manage site setup, initiation, monitoring, and close-out for clinical and post-authorisation studies as needed
* Oversee site operations including supply management and payment processes
* Track study and clinical trial status and provide progress updates to the team
* Prepare and submit documentation to EC/IRB and regulatory authorities
* Participate in investigator meetings, and relevant conferences
* Contribute to newsletters and other communications as directed by the Clinical Project Manager or designee
* Assist with audits as required
* Support process improvement initiatives and contribute to workflow enhancements
* Conduct literature reviews to support clinical and regulatory activities
Profile
* Hold a graduate degree in Biological Sciences, Nursing, Pharmacy, or a related discipline
* Postgraduate qualifications are considered an advantage
* Minimum of 2 years of proven experience as a Clinical Research Associate (CRA)
* Strong working knowledge of ICH-GCP guidelines
* Demonstrated experience in managing clinical trials and projects
Please contact me on ammar.nabi@phaidoninternational.com or please call me on +49 30 726211428 for further information.