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 Senior Clinical Specialist/Senior Clinical Research Associate.
Tasks
* Manage all aspects of clinical studies, including planning, initiation, monitoring, and close-out, ensuring compliance with ICH-GCP, GVP, and regulatory requirements.
* Conduct site evaluation and setup for SCENESSE® commercial distribution, including training and initiation activities.
* Maintain ongoing communication with sites involved in commercial distribution and clinical trials to ensure smooth operations.
* Collect and maintain essential study documentation in line with applicable regulations and quality standards.
* Monitor data collection processes and oversee pharmacovigilance and safety reporting at study sites.
* Prepare and review site visit reports, ensuring accuracy and regulatory compliance.
* Manage site-related processes, including payment tracking and reconciliation.
* Track study progress, perform quality control checks, and provide timely updates to internal teams.
* Participate in investigator meetings, internal team meetings, and relevant industry conferences.
* Assist with audits and inspections, ensuring readiness and adherence to compliance standards.
* Contribute to the development of study documents such as informed consent forms, monitoring plans, and study operating manuals.
* Support the preparation of Clinical Study Reports (CSR), publications, and other regulatory submissions.
* Develop and deliver project-specific training for junior team members and site staff.
* Prepare literature reviews and conduct scientific searches to support study objectives.
* Engage in scientific discussions on therapeutic areas, treatment strategies, study endpoints, and investigational medicinal products.
* Identify opportunities for process improvements and present recommendations to the Clinical Operations Manager.
* Contribute to internal communications, including newsletters and other project-related materials.
Profile
* Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or a related discipline.
* Postgraduate qualification is highly desirable.
* Minimum of 3 years of proven experience as a Clinical Research Associate (CRA).
* Strong understanding and practical knowledge of ICH-GCP guidelines.
* Demonstrated experience in managing clinical trials and projects effectively.
Please contact me on ammar.nabi@phaidoninternational.com or please call me on +49 30 726211428 for further information.