Shazia Amjed

Provide functional leadership for global clinical trial execution, partnering with project leaders, cross-functional teams, and vendors across the trial lifecycle. Manage vendor set-up, quote reviews and contract negotiations, and oversee vendor financials and performance to ensure quality, service, and delivery standards.

Led trial governance activities including Data Monitoring and Steering Committees, serving as escalation point to resolve study issues and protect timelines, quality, and compliance. Owned close-out and TMF audit readiness, developed key study documents, and chaired global clinical trial team sub-teams while ensuring accurate reporting to registries and tracking systems.

Assisted the Global Trial Director in delivering global clinical trials on time and within budget while adhering to quality and compliance standards. Led clinical outsourcing activities, supported issue resolution and risk mitigation, and ensured compliant study close-out including drug accountability and TMF inspection readiness.

Monitored and managed Central Lab clinical trial protocols, ensuring overall project performance and client satisfaction against milestones throughout the trial lifecycle. Produced monthly KPI and budget overviews, supported process improvements, and acted as a primary point of contact across 12+ studies.

Acted as Project Manager, coordinating customer communications to maintain alignment and address concerns, and supporting global kick-offs and investigator/vendor calls. Managed internal and external audits, ensured timely CAPA actions, supported TMF reviews and compliance for SAE/AE reporting and protocol deviations, and maintained accurate financial tracking and invoicing.

Ensured compliance with local regulations, ICH/GCP, and company and sponsor SOPs while tracking and analyzing project metrics in internal systems. Supported project managers with contracted services, contributed to protocol and project plan development, and compiled ISF/PSF binders for site initiation visits.

Coordinated multiple clinical projects to support compliant execution and timely delivery of study milestones and deliverables. Managed reports and documentation reviews, tracked financial tasks and meeting logistics, and served as the main point of contact for site questions while working across TMF and RAVE systems.

Supported clinical trial set-up by maintaining and updating study databases and producing reports using internal systems and Microsoft Office tools. Documented meeting minutes, tracked action items, and collaborated with senior managers to develop metrics that supported backlog reduction and issue resolution.

Currently studying for the PMP® (Project Management Professional) certification.

Completed a BSc in Biological Sciences (Human Health) at Heriot-Watt University.