Senior Clinical Specialist

EPM Scientific are partnered with a global leading Pharmaceutical Manufacturing company who is looking for a Senior Clinical Specialist to join their team.

Key Responsibilites:

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