Aga Khan University, Karachi Job Code:”10011769″ Qualification:
- Must have a graduate degree (MBBS), Nursing (BSc-N), Pharmacy (D Pharm).
- Advanced degree (Masters) in Nursing, Bioethics, epidemiology and biostatistics, HMP etc.
Experience:
- Must have 5-6 years of work experience in research, of which at least 2-3 years should have been spent directly in clinical trials management and Excellent knowledge in clinical practice, research administration, critical thinking and problem solving skills and decision making.
- Sound knowledge and accreditation of GCP and other local and international regulatory guidelines i.e., declaration of Helsinki, US code of federal regulations (CFR 45 and 21), CIOMS Guidelines, National Bioethics committee, DRAP
- Develop/review of all critical clinical study documents, including clinical protocols, informed consent forms, CTAs. MTAs or other study-related clinical documents and ensure compliance with ICH-GCP and other regulatory requirements.
Jobs Description:
- Manage and lead the day-to-day operations of all clinical trials run through CTU to ensure completion as per protocol and in compliance with ICH-GCP guidelines and other applicable regulatory requirements.
- Enforce successful execution of clinical trials from the protocol concept through the clinical study report.
- Lead in the recruitment, training, appraisal, retention and supervision of CTU and study team members. Act as coordinator to represent the CTU in JCIA multifunctional team (MFT) for Human Research Program (HRP).
- Develop/revise SOPs, process flows, manuals and templates where needed. Involve in strategic planning and direction of the unit.
More Information
- City Karachi
- Currency Pakistan Rupees – PKR
- Number of Vacancies 1
- Career Level Mid-Career
- Years of experience (Min) 5
- Years of experience End ( Max) 6
- Education Major MBBS, BS-N
- Preferred Nationality Pakistan
- Gender Any
- Speciality 1 Clinical Trials Management
