Assistant Manager-Research, Clinical Trials Unit
Entity: Medical College
Location: Karachi, Pakistan
Introduction
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.
As an equal opportunity employer, AKU believes in promoting a diverse and inclusive culture and is committed to adopt appropriate standards for safeguarding and promoting a respectful relationship with and between diverse workforce of its faculty, staff, trainees, volunteers, beneficiaries, wider communities, and other stakeholders with whom it works, including children and vulnerable adults and expects all employees/trainees and partners to share this commitment.
Aga Khan University invites applications for the position of Assistant Manager-Research in the Department of Clinical Trials Unit.
Responsibilities
You will be responsible for day to day activities in a Clinical Trials including a blend of Supervising and staff coordination and the implantation of policies and procedures that enhances the quality of services provided to patient.
Specifically, you will be responsible to:
- prepare and/or reviews all institutional and other regulatory documents to support clinical trial submissions
- provides an oversight for all institutional and regulatory submissions for completeness, correctness and timeliness.
- develop and maintain a quality assurance and quality control systems for ensuring quality and compliance of trials
- develop audit plan and audit tools for interventional and non-interventional studies conducted through the CTU
- assesses the compliance level of clinical trials by conducting various audits. Issues identified are communicated to the Study teams
- compile results of all CTU studies audited and share with management for feedback and action for improvement
- supervise and coach research coordinators and Research associates from study start to close out
- evaluate staff performance appraisals annually with Manager/ Director
- review all clinical trial protocols and other supporting documents and share feedback with investigators
- liaison with Sponsor, department, CRO, Investigator and Study team
- prepare and submit all institutional and regulatory applications on behalf of PI and follow up and submit responses to queries
- ongoing monitoring of the essential documents and research data for compliance and integrity.
- conduct trainings for CTU and other AKU staff involved in human subject research
- perform additional tasks as deemed appropriate by Management.
Requirements
You should have:
- a graduate degree (MBBS), Nursing (BScN), Pharmacy (Pharm D/ B- Pharmacy)
- relevant Master’s degree program is preferred
- must have 4-5 years of work experience in research/health services, of which at least 2-3 years should have been spent directly in clinical trials management
- should have knowledge and experience of dealing with regulatory affairs related to clinical trials
- excellent knowledge of ICH-GCP and other local and international regulatory guidelines i.e. DRAP, National Bioethics Committee, Institutional Ethics Committee, CIOMS Guidelines etc
- demonstrates strong analytical, problem-solving skills
- strong written and verbal communication skills
- 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.
