CLINICAL TRIALS PHARMACIST
Closing date for applications: 30 July 2021
MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We are seeking to appoint a Clinical Trials Pharmacist to join our Pharmacy team and make a positive impact in a growing and progressive CRO. You will be joining a company that put the needs and wellbeing of their people first, who are inclusive and who deliver exceptional service – together.
This role is full time and based at our Manchester site with travel to other sites as required.
The purpose of this role is to ensure all MAC Research sites comply to regulations of GCP and GMP regarding drug receipt, dispensing/preparation, storage and return of Investigational Medicinal Product (IMP)/commercial and comparator, required for studies taking place at MAC Clinical Research and ensure that all planned preventative maintenance and environmental monitoring of the Aseptic suite is performed in accordance with GMP guidelines.
Liaise with staff including the Medical Director, PI (Principal Investigator), Sub- Investigators, Clinical Manager across all MAC sites and sponsor, regarding requirements for studies of Investigational Medicinal Product (IMP)/commercial and comparator.
Ensure that documentation is completed to ensure complete accountability of study material and investigate discrepancies.
Ensure that appropriate measures are taken that Investigational Medicinal Product/commercial and comparator are kept at the appropriate storage conditions.
Develop pharmacy procedures; un-blinded and blinded dispensing of medication and supply/resupply.
Final check and release of Intravenous IMP.
Documentation of storage conditions and resolve pharmacy issues for the sites.
Investigate excursions regarding storage of study drug material.
Lead in regulatory audits and client monitoring visit of the pharmacy.
Authorise SOP’s regarding IMP/Commercial & Comparator, when necessary.
Develop and maintain a planned preventative maintenance log for the Aseptic Suite keeping a record of actions taken and liaise with the service providers to ensure timely completion of all maintenance.
Ensure environmental standards as met for the Aseptic Suite as defined in standards laid out by GMP by preparing regular weekly and monthly reports of environmental monitoring and operator qualifications.
Authorise timely corrective and preventative actions in the event of an adverse monitoring report.
Good knowledge of Good Manufacturing Practice (GMP)
Good knowledge of Good Clinical Practice (GCP)
Be a member of the General Pharmaceutical Council
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking at MAC office locations
25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years service)
Your birthday off work
Regular hours (including Christmas Day, Boxing Day and New Years Day off)
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Please note that if we receive a high volume of applications this date may be brought forwards.
Salary: Competitive + Negotiable £ Apply Now