Regional Clinical Study Manager

🕒 August 4

đŸ‡«đŸ‡· France – Remote

đŸ’” €74.1k - €92.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

đŸ§Ș Clinical Research

đŸ‘» Ghost score 2%

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Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

🧬 Biotechnology

đŸ„ 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 inspection-readiness quality, within agreed timelines and budget ‱ Lead the regional clinical operations team and oversee regional external partners ‱ Act as the regional escalation point for assigned-study issues ‱ Align regional deliverables with overall study goals ‱ Lead study planning and management from feasibility through closeout ‱ Manage start-up and recruitment timelines and track regional progress ‱ Drive trial feasibility, country allocation, and site selection ‱ Coordinate local adaptations of global study documents and regulatory/ethics submissions ‱ Maintain accurate regional and country information in study systems ‱ Collaborate with CRAs to ensure proper site execution and review/sign off monitoring reports ‱ Ensure country- and site-level Trial Master Files are created, maintained, and quality controlled ‱ Provide input on clinical supplies, drug inventories, labels, comparator-drug approvals, and reimbursement status ‱ Manage regional data collection, data entry, and query resolution ‱ Support Clinical Study Report planning and execution ‱ Monitor compliance with protocol, SOPs, ICH/GCP, and applicable regulations ‱ Ensure 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 vendors and budgets ‱ Manage investigator fees, site payments, and patient travel reimbursement activities ‱ Identify resource needs, establish contingency plans, and monitor resource utilization ‱ Provide performance feedback and mentor junior team members ‱ Line-manage study start-up and trial-monitoring staff, including work allocation, performance appraisals, hiring input, and development plans

🎯 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 the biotech, pharmaceutical, or CRO industry ‱ Proven clinical research experience, including relevant team-lead experience in clinical functions ‱ CRA experience preferred ‱ Efficient proficiency in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook ‱ Willingness to travel as required by business needs

đŸ–ïž Benefits

‱ Salary range of 74,100.00 EUR - 92,600.00 EUR ‱ Travel might be required as per business need ‱ Mentoring and professional development support for direct reports

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