Manager, Clinical Trials Unit Aga Khan University

The Aga Khan University was found in 1983 as Pakistan's first private university, Aga Khan University is a not-for-profit institution and an agency of the Aga Khan Development Network. Starting in 2000, the University expanded to Kenya, Tanzania, Uganda, United Kingdom and Afghanistan. AKU began life as a health-sciences university.

Clinical Trials Unit (CTU) is dedicated to develop a center of excellence for high quality and high impact clinical trials both nationally & internationally. The Unit promotes AKU's vision by providing leadership, consultation and facilitation in different phases of clinical trials in compliance with the International Standards and Good Clinical Practice (GCP) guidelines.

Aga Khan University invites applications for the regular full-time position of Manager in Clinical Trials Unit.

ResponsibilitiesThe Research Manager (RM) is accountable to plan, coordinate and execute all aspects of clinical trial operations. This includes feasibility planning, development of budgets, regulatory approvals, study subject recruitment, randomization, drug management, resource management, quality assurance for all clinical trials managed through CTU.

Specifically, you will be responsible to:

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

prepare initial study feasibility reports and share with sponsors and investigators

develop clinical trials budget for all CTU studies, negotiate with sponsor and get approval from HR and finance

lisaon between sponsor, CRO's and investigators. Plan, execute and lead study specific meetings (initiation meetings, site monitoring, ongoing and follow up meetings,) with sponsors and investigators and develop action plan

Periodically conduct ICH -GCP workshops for faculty and studystaff

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

keep up to date with current practices in risk management in clinical trials

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.

RequirementsYou should have:

must have a graduate degree (MBBS), Nursing (BScN), Pharmacy (D.Pharm)

advanced degree (Masters) in Nursing, Bioethics, epidemiology and biostatistics, HMP etc

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

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

excellent multitasking skills and ability to work under pressure

excellent interpersonal skills and communication ability - written and verbal in English and Urdu

leadership skills in managing staff

proven ability to organise and prioritise workload to meet deadlines

To ApplyPlease send your detailed CV by email to human.resources@aku.eduand mention the number "10011769" in the subject line.

Only shortlisted candidates will be notified.

Applications should be submitted latest byOctober 29, 2023#J-18808-Ljbffr