We are seeking a clinical trials officer 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 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.

About us

Huddersfield Pharmacy Specials (HPS) is a NHS hosted Specials manufacturing unit. Our mission is to provide high quality, affordable specials throughout the UK to both Primary and Secondary Care. At HPS we manufacture a wide range of products including dermatological, oral and topical liquids, infusion fluids and ampoules. We also provide a bespoke packaging and labelling service.

The facility has a MHRA Manufacturer Specials Licence (MS), a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)).

Job description

Job responsibilities

Main Tasks will include:

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 Investigators 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.

Duties and responsibilities of the post.

• Covers the duties of other staff during periods of sickness and absence and undertakes any other reasonable duties.
• Handles and moves goods and equipment (maximum weight 25kg), transferring them between cages, trolleys, cupboards, work areas and shelving that are at different levels.
• Complies with Trust and departmental policies relating to security and patient confidentiality ensuring that procedures are carried out in accordance with safe systems of work and current legislation.

Managing Self

• Participate in regular supervision.
• Attend all mandatory training.
• Participate annually identifying, developing, and agreeing your own development plan with your Line Manager using the Trust Appraisal.
• Comply with all Trust policies, procedures, and protocols.
• Carry out duties with due regard to the Trusts Equal Opportunity Policy.
• Seek advice and support from Line Manager whenever necessary.
• Maintain professional conduct including appearance at all times.
• Ensure maintenance of Professional Registration.

Person Specification

QUALIFICATIONS / TRAINING

Essential

• BSc in Chemistry, Pharmaceutical Science or relevant Science or Engineering Degree.
• Demonstrates commitment to CPD to maintain skills required.

Desirable

• Post graduate qualification in Clinical Trials or other relevant higher education.
• PRINCE 2 or similar project management qualification
• Specific GCP training

KNOWLEDGE, EXPERIENCE & EXPERTISE

Essential

• Experience of product development and clinical trials.
• Experience of project management
• Demonstrates knowledge of GMP and GCP gained through practical experience and / or post qualification training
• Demonstrates knowledge of pharmaceutical processes and dosage forms.

Desirable

• Knowledge of GLP and GDP
• Knowledge of drug development processes
• Toxicology / clinical pharmacology
• Post-qualification experience in a pharmaceutical or relevant industrial environment.
• Experience in delivering clinical trials or technical projects.

COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)

Essential

• Able to construct functional standard operating procedures and other documentation.
• Able to manage and prioritise own workload.
• Project management.
• Excellent interpersonal and communication skills.
• Able to remain calm and confident under pressure.
• Practical ability/manual dexterity.
• Pays attention to detail.
• Demonstrates critical thinking.
• Able to motivate, persuade and inspire staff.
• Presentation skills.
• Intermediate level computer skills (word processing, spreadsheets and database use)

Employer details

Employer name

Calderdale and Huddersfield NHS Foundation Trust

Address

Huddersfield Pharmacy Specials

Acre Mill, School Street West

Huddersfield

HD3 3ET

Any attachments will be accessible after you click to apply.

372-HPS1084