Clinical Trial Operations Lead (Phase I–IV)

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

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.