Regional Clinical Study Manager

This is a fully remote position, open to applicants in Australia, +1 more state.

📋 Description

• Lead regional clinical operations teams and supervise external partners for designated studies.

• Serve as the escalation point for regional study challenges and ensure alignment with overarching study objectives.

• Collaborate with regional stakeholders and provide updates on study progress to senior management and the Global Clinical Study Manager.

• Represent regional study teams during internal and cross-functional Clinical Study Team meetings.

• Plan and oversee assigned clinical studies from feasibility through to regional closeout.

• Manage study start-up and recruitment timelines while tracking regional progress.

• Facilitate regional trial feasibility, country allocation, and site selection.

• Coordinate local modifications of global study documents and country submissions to regulatory authorities and ECs/IRBs.

• Maintain precise regional and country information in study systems and tools.

• Collaborate with CRAs to ensure effective site execution and review/sign off on monitoring reports.

• Ensure the creation, maintenance, and quality control of country and site-level Trial Master Files.

• Provide insights on regional drug inventories, local drug labels, comparator drug regulatory approvals, and reimbursement status.

• Oversee regional trial data collection, data entry, and resolution of queries.

• Assist in the planning and execution of Clinical Study Reports.

• Monitor study compliance with protocols, SOPs, ICH/GCP, and applicable regulations.

• Ensure readiness for inspections, prepare sites for audits and inspections, and manage responses to findings.

• Lead process enhancements and contribute to work instructions and SOPs.

• Select and manage regional study vendors and oversee regional study budgets.

• Coordinate investigator fees, site payments, patient travel reimbursements, and regional resource requirements.

• Provide performance feedback and mentor junior team members as needed.

⛳️ Requirements

• Bachelor’s Degree in a scientific or healthcare discipline is required.

• Higher Degree is preferred.

• Proficiency in MS Office.

• Proficiency in Project Planning Applications.

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

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

• CRA experience is preferred.

🏝️ Benefits

• Market competitive compensation package.

• Performance-based annual bonus scheme.

• Company shares (generous welcome grant!).

• In-house and external learning and development opportunities.

• Fantastic benefits program.

• Dynamic, collaborative, supportive, inclusive, and enjoyable team environment.