Senior Pharmacist, Clinical Trials Unit at Aga Khan University Hospital

Ensuring that all clinical trials involving investigational medications in CTU are appropriately managed and maintained and that all current legislation, ICH-GCP and policies are followed;

Liaising with principal investigators and/or study coordinators / CTU Management to establish pharmacy’s role, and to implement dispensing, compounding procedures;

Communicating with, and trains staff anticipated to participate in any aspect of the clinical investigational drug trial;

Maintaining a pharmacy binder which contains a study summary, protocol, dispensing procedures, completed samples of required paperwork, dispensing checklist, fee schedule, billing procedures and any other relevant materials for each investigational trial;

Maintaining an up-to-date investigational drug trials list;

Maintaining responsibility for the management of the inventory for clinical investigational drug trials; orders, replaces and returns study materials, as required;

Communicating any concerns regarding ethical issues or deviation from established policies & procedures;

Actively engaging in investigational medication dispensing, as needed;

Providing direct supervision; maintains overall responsibility for pharmacy operations;

Supervising and provides direction to other pharmacy staff;

Delegating work assignments and checks work performed by other staff;

Providing input into performance appraisals of support staff;

Providing technical and procedural guidance;

Performing administrative responsibilities;

Attending and contributes to interdisciplinary team meetings relating to clinical investigational drug trials. Monitors pharmacy activities, daily, to ensure adherence to proper inventory record maintenance;

Completing reports including incident reports, adverse drug reaction reports, etc;

Performing education responsibilities;

Providing training to pharmacy, medical, nursing, and other relevant trust staff on clinical trial medicines and processes;

Performing communication responsibilities;

Facilitating rapport between the Department of Pharmacy, principal investigators, clinical trial coordinators, research assistants and trial sponsors;

Effectively communicatingwith colleagues, and allied health professionals;

Liaising with external agencies/organizations, as required;

Contributing information about clinical investigational drug trials to the pharmacy newsletter;

Supervising monitoring visits from CROs and Sponsor;

Setting-up and update study specific documents. Process amendments in timely manner;

Establishing and maintain all policies and procedures relating to the pharmacy clinical trials service;

Master’s degree in pharmacy and/ or additional training in Hospital pharmacy is preferred_Minimum 3-4 years’ experience in hospital pharmacy practice or experience of working in clinical trials preferably pharmacy with progressively increasing responsibilities.

Knowledge of ICH-GCP and other local and international regulatory guidelines i.e. DRAP, National Bioethics Committee, Institutional Ethics Committee etc.

Self-motivated, with strong leadership abilities.

Demonstrates strong analytical, problem-solving skills.

Strong written and verbal communication skills.Detail oriented, good organizational traits.

Must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.

Good computer skills; inclination to adopt technology to maximize efficiency.

Strong Team leading and delegation qualities

Proven ability to organize and prioritize workload to meet deadlines. Flexible approach to working hours.