Clinical Specialist

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 or please call me on +49 30 726211428 for further information.