Clinical Trials Officer
- Clinical Trials
- Band 5
- Fixed term: 18 months
- Flexible working - Up to 37.5 hours per week
- Calderdale and Huddersfield NHS Foundation Trust
- Huddersfield Royal Infirmary
- £24,907 - £30,615 per annum
- 25/04/2021 23:59
Calderdale & Huddersfield NHS Foundation Trust is a leader in the digital health revolution. With the launch of a full Electronic Patient Record in 2017 the Trust aims to be the safest, most efficient and patient centred Trust in the NHS. The launch is part of a 10-15 year ongoing project of modernisation with future opportunities for research, development in this rapidly developing field of medicine. Through working at CHFT you can be part of this innovative area aiming to bring safer and more effective care to our patients.
We are seeking a clinical trials officer to cover maternity leave and to manage the day to day delivery of Investigational Medicinal Products, work with customers to develop new IMPs, and increase the scope of our clinical trials support services including the development of IMP dossiers and Investigator’s Brochures.
The ideal candidate will have a science degree or NVQ Level 3 qualification in Pharmacy Services, or have completed the Clinical Pharmaceutical Scientist qualification. They will possess an excellent working knowledge of GMP and GCP gained through working on the delivery of clinical trials and the manufacture of IMPs or manufacture of licenced/unlicenced medicinal products. In addition they will be self-starting, highly motivated, and committed to the development of this area of business at HPS.
Main duties of the job
The post holder will be responsible for
- Delivery of clinical trials projects including preparation of supporting documentation, liaison with customers and production teams.
- Working with the Regulatory and Clinical Affairs Manager to develop new clinical trials projects and tender submissions.
Working for our organisation
Huddersfield Pharmacy Specials (HPS) is an NHS hosted Specials manufacturing unit. Our mission is to provide high quality, affordable medcines throughout the UK to both Primary and Secondary Care. The facility has MHRA MIA and Manufacturer “Specials” Licences (MS), a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)).
The unit has an ambitious plan for growth including the development of our existing clinical trials manufacturing service and increasing the level of support we offer for customers conducting clinical trials.
Detailed job description and main responsibilities
Developing Opportunities for the production of IMPs
- Contribute to the construction of tender responses for clinical trials opportunities.
- Liaison with production and development teams to validate potential approaches to the manufacture of products for new clinical trials opportunities.
Compiling clinical and technical data for Investigator’s Brochures and IMP Dossiers for regulatory applications
- Works with Development Team to schedule developmental activities including analytical work and production development batches.
- Works with regulatory advisors, study sponsors and the Regulatory and Clinical Affairs Manager to complete required regulatory dossiers including IBs and IMPDs
- Compiles required data into appropriate document formats, including summaries and reviews.
- Checks dossier information for clarity and completeness prior to submission.
Managing timelines for the manufacture and delivery of IMPs
- With Head of Production and Section Heads agrees production timelines and schedules production activities.
- Contributes to the generation of production SOPs and documentation relevant to the production of IMPs including DevBMRs and BMRs.
- Works with section heads to plan production scheduling to meet the requirements of specific trials taking into account available stability data and shelf lives.
- Manages the storage and distribution of IMPs including where required temperature controlled environments.
- Maintains appropriate documentation covering the storage and distribution of IMPs.
- Maintains project boards and tracks progress against agreed timelines.
- Maintains project plans and ensures regular updates.
Communicating with Sponsors and Investigators associated with Clinical Trials involving IMPs developed and / or manufactured at HPS
- Communicates 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.
Maintaining systems for compliance with regulatory requirements for the conduct of clinical trials and the manufacture of IMPs
- Maintains and complies with appropriate policies and SOPs to meet regulatory requirements for GMP / GCP compliance, and contributes to the development of the quality system.
- Maintains working knowledge of applicable legislation and applicable good practice i.e. GCP, GMP, GLP, GDP.
- Attends meetings and conferences relevant to the provision of clinical trials services.
Manufacture of clinical trials products
- Participates in the manufacture of clinical trials products and the validation of systems and equipment used in the manufacture and packaging of clinical trials products.
Participates in the Performance Development Review process.
- BSc in Chemistry, Pharmaceutical Science or relevant Science or Engineering Degree. Or NVQ level 3 in appropriate science subject
- Post graduate qualification in Clinical Trials or other relevant higher
- PRINCE 2 or similar project management qualification
- Demonstrates commitment to CPD in order to maintain skills required
- Specific GCP training
- Experience of product development and clinical trials
- Experience of project management
- Post-qualification experience in a pharmaceutical or relevant industrial environment.
- Experience in delivering clinical trials or technical projects
Special Knowledge/ Expertise
- Demonstrates knowledge of GMP and GCP gained through practical experience and / or post qualification training.
- Demonstrates knowledge of pharmaceutical processes and dosage forms.
- Knowledge of GLP and GDP
- Knowledge of drug development processes
- Toxicology / clinical pharmacology
Documents to download
Further details / informal visits contact
- Dr Burrinder Grewal
- Job title
- Managing Director
- Email address
- Telephone number
- Additional information