Experience

Manchester University NHS Foundation Trust

• United Kingdom
• Hospitals and Health Care
• 700 & Above Employee

• Consultant Pharmacist-Clinical Trials and ATMPs

  • Jul 2019 - Present

  Head of Pharmacy Clinical Trials Service and ATMPs

• Pharmacy Head of Research and Innovation

  • Oct 2016 - Jul 2019



NHS

• Hospitals and Health Care
• 700 & Above Employee

• Member of National Pharmacy Clinical Trials Advisory Group

  • Sep 2016 - Present

• Lead Clinical Trials Pharmacist

  • Feb 2013 - Oct 2016

  UHSM is a tertiary University Hospital leading in respiratory (including cystic fibrosis), cardiology and breast cancer treatment/prevention. But we also conduct other speciality trials ranging from paediatrics, haematology, stroke, diabetes, pulmonary oncology etc.As part of my current role in UHSM I manage the clinical trials pharmacy service for the Trust and a Respiratory and Allergy Clinical Research Facility.I work very close with Leading Professors, consultants and researchers in design and reviewing Clinical Trials of Investigational Medicinal Products. This includes CTIMPs' IMP section, inclusion/exclusion criteria, safety and pharmacovigilance of the protocol, Ethics and MHRA applications. I also design, complete and evaluate risk assessments and monitoring plans (risk based). I verify the pharmacy manuals design and pharmacy pro-forms to assess and monitor local pharmacies for multi centre sponsored trials in my organisation, to meet legal, GCP and GMP requirements.I'm the pharmacy representative of the Sponsor Oversight Committee in my organisation. During the past 2 years working as a UHSM Lead Clinical Trials Pharmacist my main achievements have been as follows:• Successful preparation for MHRA GCP systems inspection as the main pharmacy contact• Implementation and management of change in practice in the CT pharmacy service: -New CT area organisation and new procedures in line with GCP. -Design and implementation of new quality systems• Creation, implementation and delivery of CT Training: -Distribution of training packs across entire NW CT Network to be piloted in different organisations. -The training packs were also presented at the Pharmacy practice day 23 June 2014 RPS in London.• Recently approached to deliver a training session to the NIHR Greater Manchester Research Management and Governance team about how pharmacy supports CTIMPs.



Health Research Authority; National Research Ethics Service (NRES)

• Expert Member of Research Ethics Committee North West-GMC

  • Jan 2012 - Sep 2016

  As a pharmacist expert member of the Central Manchester ethics committee, my role consists of the identification of ethical issues regarding the conduct of any CTIMP submitted (Including Phase I), with special attention to IMP management. As a pharmacist expert member of the Central Manchester ethics committee, my role consists of the identification of ethical issues regarding the conduct of any CTIMP submitted (Including Phase I), with special attention to IMP management.



Central Manchester & Manchester Children's Foundation Trust

• Paediatric Clinical Trials Pharmacist

  • Feb 2010 - Feb 2013

  Management of commercial and non commercial paediatric clinical trials.Main achievements:• Structural reorganisation of the management and delivery of trials, enabling an increase in one year from 10 to 70 paediatric CTIMPs.• To assist and lead in the Paediatric CT preparation for MHRA GCP systems inspection.• To be appointed as an expert member of the Central Manchester Ethics Committee• To efficiently manage performance, and develop paediatric pharmacy CT members of staff including challenging characters• To implement new working patterns to establish clear and regular means of communication with other pharmacy services and the paediatric research teams.



NHS

• Paediatric Clinical Pharmacist

  • 2009 - 2010

  Secondary medicine: Admissions ward.Tertiary medicine: Cistic fibrosis, metabolics, cardiology, rheumatology, renal and renal transplant. Secondary medicine: Admissions ward.Tertiary medicine: Cistic fibrosis, metabolics, cardiology, rheumatology, renal and renal transplant.



The University of Manchester

• Post Doctoral Research Associate

  • 2007 - 2009

  Fields: Nerve Regeneration and Diabetic Neuropathy.Main achievements:• Publication of my work as per CV in high impact scientific journals, as first author.• To be invited to present my work at international conferences, as per CV.• Effectible management of the Lab, technicians and PhD students during two maternity leaves of my line manager and director of our lab. Fields: Nerve Regeneration and Diabetic Neuropathy.Main achievements:• Publication of my work as per CV in high impact scientific journals, as first author.• To be invited to present my work at international conferences, as per CV.• Effectible management of the Lab, technicians and PhD students during two maternity leaves of my line manager and director of our lab.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Visiting Scientist

  • 2002 - 2003

  Awarded fully funded European grant: Leonardo da Vinci programme of the European Community as a visitor scientist for 6 months.In my 3rd month the company extended my contract as a visitor scientist for a further 6 months.Working on 2 different neuroscience research projects on schizophrenia and anxiety.Main achievements:• In that period my work contributed to 2 publications in very high impact scientific journals. Awarded fully funded European grant: Leonardo da Vinci programme of the European Community as a visitor scientist for 6 months.In my 3rd month the company extended my contract as a visitor scientist for a further 6 months.Working on 2 different neuroscience research projects on schizophrenia and anxiety.Main achievements:• In that period my work contributed to 2 publications in very high impact scientific journals.