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.
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