Assistant Manager ( JP-301)

Ziauddin University; Karachi Division; On-site; PKR 1,800,000 - 2,400,000; Full time

Job summary

Ziauddin University seeks a senior professional to lead Clinical Trial Operations, ensuring end-to-end management of trials from planning to reporting. You will supervise data management, pharmacovigilance, and laboratory workflows, ensuring GCP adherence and regulatory readiness.

The role requires 5–6 years in clinical research with leadership experience, and a strong focus on quality, safety, and sponsor coordination. This is a full-time on-site position at the CTU.

Qualifications

• Pharm-D/MBBS/BDS with Master’s in Health Sciences or related field; GCP certification.
• Minimum 5–6 years of professional experience in clinical research or trial operations.
• Leadership experience of at least 2 years in a management role.

Responsibilities

• Oversee end-to-end execution of Phase I–IV trials, ensuring timelines and sponsor deliverables.
• Ensure subject safety, eligibility, and informed consent, and report AEs/SAEs.
• Guarantee accurate EDC data entry and source documentation per ALCOA+ and ICH-GCP.
• Supervise lab activities and IATA-compliant shipment of biological samples.
• Oversee CTU IP management, storage, temperature control, and reconciliation of IPs.
• Direct preparation and submission of CTAs and ethics applications per ICH-GCP E6R3, DRAP, and guidelines.
• Lead CAPA, audits, and sponsor/regulatory inspections readiness.
• Manage study budgets, expenditures, and sponsor invoicing; support contract negotiations.

Skills

Clinical research

Clinical trial operations

Leadership

Budgeting & contracts

Education

MBBS/ Pharm-D/ BDS

Master’s in Health Sciences or related field

Good Clinical Practice (GCP) certification

Job description

• Pharm-D/ MBBS/ BDS with at least Master’s Degree in Health Sciences or related fieldCertification in Good Clinical Practice

Experience

• Minimum 5 – 6 years of professional experience in Clinical research, Clinical trial operations, orrelated fields, out of which at least two years of working experience in leadership or managementrole.

Job Description

• 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.