Regional Clinical Study Manager

This is a fully remote position, open to applicants in Australia.

📋 Description

• Responsible for the delivery of regional studies, ensuring inspection readiness quality is met within established timelines and budget constraints.

• Directs the regional clinical operations team, overseeing external partners engaged at the regional level, and serves as the escalation point for issue resolution related to the assigned study.

• Guarantees that regional deliverables are aligned with the overall objectives of the study.

• Oversees the planning and management of the assigned clinical study(ies) from feasibility through to closeout activities for the region, in accordance with global study timelines.

• Ensures the timely preparation of local adaptations of global study documents, such as informed consent forms, collaborating closely with key stakeholders to facilitate timely submissions to regulatory bodies and ECs/IRBs.

⛳️ Requirements

• A Bachelor’s Degree in a scientific or healthcare discipline is required; a Higher Degree is preferred.

• A minimum of 4 years of progressive experience in clinical research within the biotech, pharmaceutical, or CRO industry.

• Demonstrated experience in clinical research, including relevant experience as a team lead in clinical functions.

• Prior experience as a Clinical Research Associate (CRA) is preferred.

• Proficient in computer skills, including MS Office and Project Planning Applications.

🏝️ Benefits

• Competitive market compensation package, which includes a performance-based annual bonus scheme.

• Company shares with a generous welcome grant.

• Opportunities for in-house and external learning and development.

• Comprehensive benefits program.