Global Clinical Data Governance Lead

Lead Group; Western Australia; Sur place; AUD 180 000 - 280 000; Plein temps

Résumé du poste

Lead Group partners with an Australian medical technology company to recruit an experienced Clinical Data Management Program Lead. You will own data integrity, governance and systems across a global research portfolio.

This role blends strategic influence with hands-on delivery, collaborating with Clinical Operations, R&D, Technology, Quality and Regulatory teams to shape data strategy for SaMD and heart-disease diagnostics, with travel across US and Western Australia time zones.

Qualifications

• 12+ years of clinical data management experience in medical devices/SaMD.
• Proficient in ICH GCP, CDISC and/or FHIR.
• Experience with EDC platforms and clinical data systems.
• Strong data privacy and regulatory knowledge (HIPAA, GDPR, 21 CFR Part 11).
• Ability to develop data standards, SOPs and governance processes.
• Experience with real-world data and analytics tools (Python or R) is a plus.

Responsabilités

• Lead development of global clinical data governance, standards and SOPs.
• Oversee secure data storage, integration and accessibility across clinical databases and research systems.
• Develop data management plans, data specifications and data flow documentation.
• Lead data cleaning, reconciliation and transfers to ensure data quality.
• Manage data acquisition from external vendors and research partners.
• Represent data management in audits and regulatory reviews.
• Build and mentor a data management and analytics team.

Connaissances

Data governance

Data standards

Stakeholder influence

Strategic leadership

Outils

EDC platforms

Clinical databases

AWS S3

Python/R

Description du poste

Lead Group partners with an Australian medical technology company to recruit an experienced Clinical Data Management Program Lead. You will own data integrity, governance and systems across a global research portfolio.

This role blends strategic influence with hands-on delivery, collaborating with Clinical Operations, R&D, Technology, Quality and Regulatory teams to shape data strategy for SaMD and heart-disease diagnostics, with travel across US and Western Australia time zones.