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.
Clinical Data Management Lead in Perth employer: Lead Group
This business advisory firm in Melbourne is an exceptional employer, offering a supportive work culture that prioritises employee growth and development. With structured training events, flexible work hours, and a strong emphasis on work-life balance, employees are encouraged to enhance their skills while enjoying a vibrant social club and fitness activities. Joining this team means being part of a collaborative environment where your contributions are valued and career progression is actively supported.
