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Clinical Trials Officer

2 months ago

Huddersfield, Kirklees, United Kingdom Calderdale and Huddersfield NHS Foundation Trust Full time
About the Role

We are seeking a highly skilled Clinical Trials Officer to join our team at Calderdale and Huddersfield NHS Foundation Trust. As a key member of our pharmaceutical development team, you will play a crucial role in the management of clinical trials, ensuring the delivery of high-quality Investigational Medicinal Products (IMPs) to our customers.

Key Responsibilities
  • Project Management: Manage clinical trials projects from initiation to completion, ensuring timely delivery of IMPs and supporting documentation.
  • Regulatory Compliance: Work closely with the Regulatory and Clinical Affairs Manager to develop new clinical trials projects and tender submissions, ensuring compliance with GMP and GCP regulations.
  • IMP Development: Contribute to the construction of tender responses for clinical trials opportunities, liaising with production and development teams to validate potential approaches to the manufacture of products for new clinical trials opportunities.
  • Documentation and Reporting: Compile clinical and technical data for Investigators Brochures and IMP Dossiers for regulatory applications, ensuring accuracy and completeness.
  • Timeline Management: Manage production timelines and schedules, working with the Head of Production and Section Heads to ensure timely delivery of IMPs.
  • Communication and Collaboration: Communicate project plans, timelines, and status updates to inform sponsors and investigators of actions and progress on the development of IMPs and support for clinical trials.
  • Regulatory Affairs: Maintain and comply with appropriate policies and SOPs to meet regulatory requirements for GMP/GCP compliance, contributing to the development of the quality system.
Requirements
  • Qualifications: BSc in Chemistry, Pharmaceutical Science, or relevant Science or Engineering Degree.
  • Experience: Experience of product development and clinical trials, project management, and knowledge of GMP and GCP gained through practical experience and/or post-qualification training.
  • Skills: Excellent interpersonal and communication skills, ability to manage and prioritize own workload, project management, and intermediate level computer skills.
About Us

Calderdale and Huddersfield NHS Foundation Trust is a leading healthcare provider, committed to delivering high-quality patient care. Our pharmaceutical development team is dedicated to providing innovative solutions for clinical trials, and we are seeking a talented Clinical Trials Officer to join our team.