Regional Clinical Study Manager – Senior Manager

🔥 18 minutes ago

🌐 Australia, New Zealand – Remote

🇦🇺 Australia – Remote 🇳🇿 New Zealand – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget • Lead the regional clinical operations team and oversee external regional partners • Act as point of escalation for regional study issues • Ensure regional deliverables align with overall study goals • Lead planning and management of assigned clinical studies from feasibility through regional closeout • Manage study startup and recruitment timelines and track progress • Drive trial feasibility, country allocation, and site selection for the assigned region • Provide regional input on global study plans • Ensure local adaptations of global study documents and timely regulatory and ethics submissions • Ensure regional and country information in study systems remains current • Collaborate with CRAs to ensure proper site execution and review and sign off monitoring reports • Ensure country and site-level Trial Master Files are created, maintained, and quality controlled • Provide input on regional drug inventories, local drug labels, regulatory approvals, and comparator reimbursement status • Manage regional trial data collection, data entry, and query resolution • Support Clinical Study Report planning and execution • Monitor compliance with protocols, SOPs, ICH/GCP, and applicable regulations • Ensure inspection readiness and prepare sites for audits and inspections • Address escalated site issues and implement solutions • Lead sharing of site learnings and best practices • Contribute to work instruction and SOP development and optimization • Manage regional study vendors and budgets • Coordinate investigator fees, site payments, and patient travel reimbursement activities • Identify regional resource needs and monitor resource utilization • Provide performance feedback and mentor junior team members

🎯 Requirements

• Bachelor’s Degree in a scientific or healthcare discipline required • Higher Degree preferred • MS Office proficiency • Project Planning Applications proficiency • 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry • Proven experience in clinical research, including relevant experience as team lead in clinical functions • Experience as CRA preferred

🏖️ Benefits

• Market competitive compensation package including 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 fun team environment