Manager - Clinical Trial Unit

About the job

Role Description The Manager – Clinical Trial Unit is a full-time, on-site role based in the Karachi Division. This position oversees the planning, execution, and monitoring of clinical trials conducted within the university and affiliated centers, ensuring adherence to protocols, regulatory standards, and ethical guidelines. The role includes managing clinical operations, coordinating trial timelines, supervising study staff, and maintaining high-quality documentation and data integrity. The manager collaborates with principal investigators, research teams, and administrative departments to support trial feasibility assessments, resource allocation, and performance reporting. Day-to-day responsibilities also involve optimizing operational workflows, resolving trial-related issues, and contributing to continuous improvement of clinical research processes and outcomes.

Qualifications

• Minimum 10 years of professional experience in Clinical research, Clinical trial operations, or
• related fields, out of which at least two years of working experience in leadership or management role.
• Here is a hyper-condensed version optimized for a job ad. It strips out the procedural details but retains every single key domain Ops, Safety, Data, Lab, Shipping, IP, Regulatory, Finance, HR, and Stakeholders so no critical responsibilities are missed.

Key Responsibilities

• Clinical Trial Operations: Oversee end-to-end execution of Phase I–IV trials, managing timelines, recruitment, and resource allocation to meet sponsor deliverables.
• Participant Safety & Coordination: Ensure subject welfare, eligibility, and informed consent compliance, while managing the reporting of AEs/SAEs and protocol deviations.
• Data Management & Quality: Guarantee accurate, timely EDC data entry and source documentation adhering strictly to ALCOA+ and GCP principles.
• Lab & Sample Oversight: Supervise laboratory activities, tracking, and IATA-compliant shipment of biological samples including PK/biomarkers, while managing temperature excursions.
• Investigational Product IP Management: Oversee CTU pharmacy operations, ensuring strict temperature control, storage, accountability, and reconciliation of IPs.
• Regulatory & Ethics Compliance: Direct preparation and submission of CTAs and ethics applications in compliance with ICH-GCP E6R3, DRAP, and institutional guidelines.
• Quality & Inspection Readiness: Maintain ISF/eISF compliance and lead CAPA development, internal audits, and external sponsor/regulatory inspections.
• Finance & Budgeting: Manage study budgets, expenditures, and sponsor invoicing; support contract negotiations and internal department coordination.
• Team & Stakeholder Management: Lead and evaluate CTU staff, manage professional development, and act as the primary liaison for sponsors, CROs, and business development.
• Proficiency in using clinical trial management systems, research databases, and standard office software.