Regional Clinical Study Manager

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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

• Deliver assigned regional clinical studies with inspection readiness, within agreed timelines and budget • Lead the regional clinical operations team and external regional study partners • Act as escalation point for regional study issues and align regional deliverables with overall study goals • Provide study progress updates to senior management and the Global Clinical Study Manager • Represent the regional study team at internal and cross-functional Clinical Study Team meetings • Plan and manage assigned clinical studies from feasibility through regional closeout • Manage study start-up and recruitment timelines and track regional progress • Drive regional trial feasibility, country allocation, and site selection • Coordinate local adaptations of global study documents and country submissions to regulatory authorities and ECs/IRBs • Maintain current regional and country information in study systems and tools • 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, comparator drug regulatory approval, and reimbursement status • Manage regional trial data collection, data entry, and query resolution • Support Clinical Study Report planning and execution • Monitor compliance with protocol, SOPs, ICH/GCP, and applicable regulations • Maintain regional inspection readiness and prepare sites for audits and inspections • Share learnings and best practices and improve study efficiency and quality • Select and manage regional study vendors and manage regional study budgets • Coordinate investigator fees, site payments, and patient travel reimbursement • Identify regional resource needs, establish contingency plans, 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 • Exceptions might be made for candidates with relevant clinical operations experience • 4 or more years of progressive experience in clinical research within biotech, pharma, or CRO industry • Proven clinical research experience, including relevant experience as a team lead in clinical functions • Experience as a CRA preferred • Computer skills: MS Office and project planning applications • Knowledge of clinical trial feasibility, country allocation, site selection, study start-up, recruitment, data collection, and query resolution • Knowledge of clinical research quality requirements, including study protocols, SOPs, ICH/GCP, and applicable regulations • Ability to manage vendors, budgets, investigator fees, site payments, and patient travel reimbursement activities • Ability to lead regional clinical operations teams and mentor junior team members

🏖️ Benefits

• Salary range of 281,600.00 PLN - 352,000.00 PLN • Full-time employment • Remote work