Research Manager (Clinical Trials Unit)

Research Manager (Clinical Trials Unit)

Entity: Aga Khan University

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.

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

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.

Responsibilities:

The 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.

The RM supervises the CTU personnel and study teams and ensures that allocated studies are conducted to the highest scientific and regulatory standards, as well as completed within time and budget limits. The RM also ensures that the CTU is always ready for audit and inspection activities by regulators, sponsors and quality surveyors like the JCI, DRAP etc.

• Participate in strategic planning with CTU leadership and interpret the unit’s strategy to establish business priorities that support long-term direction. Provide guidance and facilitation to researchers to ensure compliance with applicable regulatory requirements.
• Plan, coordinate, and execute all aspects of clinical trial operations, including feasibility assessments, budgeting, regulatory submissions, participant recruitment, drug accountability, resource management, and quality assurance.
• Guide novice researchers (residents, nursing faculty, and other colleagues) on protocol writing and budget development.
• Develop and review key study documents, including protocols, informed consent forms, CTAs, MTAs, CRFs, and ensure compliance with ICH-GCP and other regulatory frameworks.
• Develop clinical trial budgets for CTU studies, negotiate with sponsors, and obtain internal approvals from HR and Finance.
• Prepare and submit ERC applications on behalf of the PI, track approvals, respond to queries, and submit progress reports.
• Process grants checklists and seek approvals from all relevant entities (investigators, HR, Finance, Legal, Research Office, Department Head, and Dean of the Medical College).
• Negotiate and execute clinical trial agreements, confidentiality agreements, and material transfer agreements with sponsors, Legal, Finance, and the Research Office.
• Collaborate with investigators, research coordinators, and team members for smooth trial operations. Oversee CTU and other research staff to ensure compliance with institutional and regulatory requirements.
• Serve as liaison between sponsors, CROs, and investigators; lead initiation, monitoring, and follow-up meetings.
• Conduct periodic ICH-GCP workshops for faculty and study staff.
• Manage and supervise day-to-day operations of all CTU-managed trials, ensuring compliance with regulatory and institutional guidelines.
• Stay updated on current practices in risk management for clinical trials and implement mitigation strategies. Train personnel in risk-management practices.
• Lead recruitment, training, supervision, appraisal, and retention of CTU and study team members. Conduct interviews for new staff in coordination with the Director and manage the recruitment process.
• Evaluate annual performance appraisals with the Director.
• Prepare job descriptions for CTU and contractual staff as required.
• Liaise with Radiology, Pharmacy, HIMs, Laboratory, and inpatient/outpatient units for clinical-trial-related matters.
• Represent CTU in JCIA multifunctional teams (MFT) for the Human Research Program (HRP).
• Train new CTU staff (pharmacists, research coordinators, research assistants) on unit SOPs and institutional policies.
• Develop, revise, and implement SOPs, process flows, manuals, and templates.
• Conduct sessions on protocol writing, budget development, and practical aspects of conducting clinical trials for residents, faculty, graduate students, and nursing staff upon request.
• Develop audit tools for interventional and non-interventional studies. Train departmental representatives on audit tools and compile audit results for management review and action.
• Support the Director, CTU by providing expert guidance and, when required, officiating on their behalf.
• Review and approve clinical trial protocols in accordance with institutional and regulatory standards.
• Conduct weekly administrative meetings with CTU staff to review progress and address operational needs.
• Hold regular meetings with sponsors to provide updates on study progress and address concerns.
• Supervise and mentor Study Coordinators and Research Assistants throughout all phases of clinical trial management, from study initiation to close-out.
• Supervise and train CTU personnel, including Laboratory Technologists, Pharmacists, Research Nurses, and Administrative Assistants, on day-to-day operational tasks.
• Act as the primary point of contact for all internal and external stakeholders.
• Allocate clinical space to studies based on operational needs and study requirements.
• Identify and anticipate operational risks across studies, implement mitigation strategies, and escalate issues to senior management when required.
• Develop subject enrollment plans for CTU trials in collaboration with Principal Investigators and ensure effective implementation.
• Lead CTU and study teams during emergencies and ensure proper incident management.
• Oversee and supervise daily subject visit management within the CTU.
• Approve clinical supplies and equipment orders within delegated authority.
• Resolve day-to-day operational issues—ranging from routine to complex—and develop appropriate action plans.

Requirements:

You should have:

• MBBS, BScN, or B-Pharmacy/Pharm-D (mandatory)
• Master’s degree preferred (e.g., Bioethics, MBA, Hospital Management)
• Active knowledge of international clinical research standards; membership in professional bodies (AACI, CRI, SOCRA, ACRP) is an advantage
• Should 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.
• Should have knowledge and experience of dealing with all regulatory affairs as related to clinical trials.
• Should have knowledge and experience of going through and participating in audit and accreditation processes as related to research.
• 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.
• Strong Team leading and delegation qualities.
• Excellent interpersonal skills and communication ability - written and verbal in English and Urdu.
• Proficiency in the use of computers and related Office software.
• Superior understanding of and making budgets.
• Social skills in dealing with external clients.
• Leadership skills in managing staff.
• Proven ability to organise and prioritise workload to meet deadlines.
• Flexible approach to working hours.

Comprehensive employment reference checks will be conducted.