Regional Clinical Study Manager – Senior Manager

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

📋 Description

• Responsible for the timely delivery of regional studies with the necessary inspection readiness quality, adhering to agreed budgets.

• Lead the regional clinical operations team and manage external partners in the region.

• Serve as the escalation point for issues related to regional studies.

• Ensure that regional deliverables are in sync with the overall objectives of the study.

• Oversee the planning and management of assigned clinical studies from feasibility to regional closeout.

• Manage timelines for study startup and recruitment, while tracking progress effectively.

• Facilitate trial feasibility assessments, country allocations, and site selections for the designated region.

• Provide regional insights for global study plans.

• Ensure timely local adaptations of global study documents and manage regulatory and ethics submissions.

• Keep regional and country information in study systems up-to-date.

• Collaborate with Clinical Research Associates (CRAs) to guarantee proper site execution and review monitoring reports for approval.

• Create, maintain, and ensure quality control of country and site-level Trial Master Files.

• Offer input regarding regional drug inventories, local labeling, regulatory approvals, and the status of comparator reimbursements.

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

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

• Monitor adherence to protocols, standard operating procedures (SOPs), ICH/GCP, and relevant regulations.

• Ensure readiness for inspections and prepare sites for audits.

• Address escalated issues at sites and implement appropriate solutions.

• Lead the sharing of insights and best practices from sites.

• Contribute to the development and optimization of work instructions and SOPs.

• Manage regional study vendors and budgets efficiently.

• Coordinate activities related to investigator fees, site payments, and reimbursement for patient travel.

• Identify resource needs within the region and monitor the utilization of those resources.

• Provide performance feedback and mentorship to junior team members.

⛳️ Requirements

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

• A higher degree is preferred.

• Proficiency in MS Office applications.

• Familiarity with project planning applications is essential.

• 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.

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

🏝️ Benefits

• Competitive compensation package that 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.

• A dynamic, collaborative, supportive, inclusive, and enjoyable team environment.