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Senior clinical specialist

Egham
Permanent
Clinical specialist
Posted: 3h ago
Offer description

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 Pharmaceutical Manufacturing company is looking for a Senior Clinical Specialist 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 or please call me on 49 30 726211428 for further information.

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