Clinical Data Management Lead

Lead Group; Western Australia; On-site; AUD 180,000 - 280,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Data governance

Data standards

Stakeholder influence

Strategic leadership

Tools

EDC platforms

Clinical databases

AWS S3

Python/R

Job description

Clinical Data Management Program Lead | Medical Technology

Shape the clinical data strategy behind technology advancing the diagnosis of heart disease.

Lead Group is partnering with an innovative Australian medical technology company to recruit an experienced Clinical Data Management Program Lead.

Reporting to the Global Head of Clinical Operations, you will take ownership of clinical and research data integrity, governance and systems across a global research portfolio. This opportunity combines strategic influence with hands‑on delivery, working closely with Clinical Operations, R&D, Technology, Quality and Regulatory teams.

The opportunity

• Lead the development of global clinical data governance, standards and SOPs.
• Oversee secure data storage, integration and accessibility across clinical databases, data lakes and research systems.
• Develop data management plans, data specifications and data flow documentation, contributing to study reports and regulatory submissions.
• Lead data cleaning, reconciliation and transfers to ensure complete, accurate and consistent study data.
• Manage data acquisition from external vendors, academic institutions and research partners.
• Represent clinical data management in audits, compliance reviews and senior leadership discussions.
• Build and mentor a data management and analytics team as business needs evolve.

About you

You bring substantial clinical research data management experience—ideally 12+ years—within medical devices, biotechnology or Software as a Medical Device (SaMD).

Your background will include:

• Strong knowledge of clinical research requirements and standards, including ICH GCP, CDISC and/or FHIR.
• Experience managing EDC platforms, clinical databases and associated data systems.
• Understanding of data privacy, security and electronic records requirements, including HIPAA, GDPR and 21 CFR Part 11.
• A track record of developing practical data standards, SOPs and governance processes.
• The ability to influence senior stakeholders while remaining close to operational delivery.

Experience with real-world data/evidence, AWS/S3, Python or R would be highly regarded.

Why consider this role?

You will have the opportunity to shape how clinical data supports product validation, research and regulatory evidence within a growing medical technology business addressing a significant global health challenge.

The role requires flexibility to collaborate across US and Western Australian time zones, with travel as required.