Assistant Manager ( JP-301)

Ziauddin University · Karachi, Pakistan

FULL TIME

Job Description

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

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.

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.

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