Clinical Trials Operational Manager (Pharmacist or Technician)

Responsible for operational management of the pharmacy clinical trials service in line with the pharmacy Clinical Trials Policy, the international ethical and scientific quality standard laid down in The International Conference on Harmonisation guidelines for Good Clinical Practice relating to trials (ICH GCP) and The EU Clinical trials directive (2001/20/EC) as transposed into UK law by the Medicines for Human Use (Clinical Trials ) Regulations 2004 (the legislation), and any other legislation or standards for the conduct of clinical trials Responsible for writing and implementing Standard Operating Procedures for clinical trials in accordance with the Pharmacy Clinical Trials Policy Responsible for organising and delivering induction training and competency validation programmes for clinical trials and GCP for all levels of staff within the pharmacy Responsible for instigating internal audit programmes to ensure compliance with GCP and current clinical trials legislative requirements