Detailed job description and main responsibilities Developing and implementing a strategy for the MFT pharmacy clinical trials department.
Reviewing the medicines and pharmacy components of clinical trial proposals to assess their compliance to ethical guidelines, GCP, GMP and current legislation.
Reviewing clinical trial proposals to ensure that all pharmacy information is available, feasible and correct in terms of clinical, technical and dispensing information and documentation e.g. investigators brochure and pharmacy manuals to identify and resolve issues identified by working with members of the pharmacy department, Trust R and D, Sponsors and if applicable, manufacturers.
Attending meetings with Investigators and trial companies at all appropriate stages e.g. feasibility, initiation, monitoring and close out.
Managing the contract process for all pharmacy clinical trials including IMP management, costing and financial management.
Assessing of trial amendments and communicating and managing changes appropriately.
Participating in R and D committee meetings as appropriate. Ensure performance against key performance indicators including pharmacy approvals is met
Advising R and D on IMP related queries / incidents including drug recalls and serious breaches.
Liaising with investigators and sponsors regarding the setting up, on-going monitoring and closing of clinical trials. Ensuring close out and archiving of site studies is achieved.
Developing and maintaining systems to ensure that all pharmacy staff know when
To lead, support and undertake pharmacy practice and clinical research and audits.
Please note, if you are considering applying for a role within our organisation we do recommend that staff are fully vaccinated against Covid-19, this is no longer a mandatory requirement.

Person specification Qualifications Essential criteria

• Master's degree in Pharmacy
• Registered with the General pharmaceutical Council as a Pharmacist in the UK (or eligible to be)
• Specialist post graduate qualification such as clinical diploma or equivalent experience

Experience Essential criteria

• Proven experience of delivering responsibilities and objectives to time in previous posts
• Previous significant experience of working in clinical trials at advanced level including feasibility assessments
• Demonstrate experience and ability to manage or supervise a range of projects
• Experience of managing and motivating staff, appraising and giving feedback

Knowledge Essential criteria

• Demonstrates knowledge of all aspects of GCP, GMP and QA and clinical trial legislation
• Knowledge of and ability to apply all aspects of regulatory legislation and guidelines
• Demonstrate expert knowledge covering a range of pharmacy services and able to provide highly specialist advice

Skills Essential criteria

• Advanced IT skills - including MS Word, Excel, email and PowerPoint
• Demonstrates ability to identify problems, analyse root cause and propose solutions for complex problems
• Influencing and negotiating skills

Values Based Question Essential criteria

• Give an example of a time where you have demonstrated a 'can do' attitude (including the situation you were in) and the outcome

Please note that we do not accept applications via CV or recruitment agencies.
This post will close before the intended closing date should sufficient number of suitable applications be received. Therefore, if you are interested in applying for this role, we suggest that you do so at the earliest opportunity.
Applications are welcomed from applicants who wish to apply for a position on the basis of a smarter or flexible working arrangement. Where candidates are successful at interview, such requests will be taken under consideration and accommodated where the needs of the service allow.
We welcome applications irrespective of people's age, disability, gender identity and gender expression, race or ethnicity, religion or belief, sexual orientation, or other personal circumstances. We have policies and procedures in place to ensure that all applicants are treated fairly and consistently at every stage of the recruitment process, including the consideration of reasonable adjustments for people who have a disability.
All staff no matter where they work or which age group of patients they work with must be aware of their responsibility to act when they feel a child, young person or vulnerable adult has been or is at risk of abuse.
We are a fully non-smoking Trust. Smoking is completely prohibited in all Trust buildings, grounds and car parks for patients, visitors, staff and contractors.
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