Senior Clinical Specialist

4 days ago

Egham, Surrey, United Kingdom EPM Scientific Full time

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 for further information.

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