Clinical Data & Device Specialist — Trials & Compliance

Story Terrace Inc.; Greater London; Vor Ort; GBP 65.000 - 90.000; Vollzeit

Zusammenfassung

SAVA in London is seeking a Clinical Data & Device Specialist to support clinical operations projects with a strong focus on data quality, device management and system design. You will manage data activities from start-up through database lock, coordinate investigational device shipments, tracking, inventory and accountability, and ensure full traceability between sites and sponsor.

This hands-on role requires collaboration with Clinical Affairs, Quality & Regulatory, and Technical teams to

Qualifikationen

• Experience in clinical data management from start-up to lock.
• Knowledge of EDC, eTMF, and study documentation.
• ISO 14155 and ICH GCP understanding.
• Medical device regulatory requirements.
• Strong organizational and detail orientation.

Aufgaben

• Manage data activities from start-up to lock and DB lock.
• Oversee investigational device shipments, inventory, and accountability.
• Design and review CRFs, DMPs, and data review plans.
• Monitor data across EDC, eTMF, and study systems for compliance.

Kenntnisse

Clinical data management

Data integrity

Device management

Regulatory compliance

Cross-functional collaboration

Documentation control

Quality awareness

Ausbildung

Bachelor's in Biomedical Engineering

Tools

EDC systems

eTMF systems

Jobbeschreibung

SAVA in London is seeking a Clinical Data & Device Specialist to support clinical operations projects with a strong focus on data quality, device management and system design. You will manage data activities from start-up through database lock, coordinate investigational device shipments, tracking, inventory and accountability, and ensure full traceability between sites and sponsor.

This hands-on role requires collaboration with Clinical Affairs, Quality & Regulatory, and Technical teams to