Senior Clinical Study Manager

🔥 3 minutes ago

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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

• Act as line manager for Clinical Study Managers in the assigned country or countries • Plan, assign, and direct work; assess performance; and guide direct reports' professional development • Allocate staff to clinical research projects based on experience and training • Ensure clinical trial protocols and activities follow ICH guidelines, GCP, local regulations, and applicable SOPs • Collaborate with regional and country teams to maintain study timelines and quality standards • Support clinical trials in the country and provide local expertise • Drive best practices, process improvement, and operational efficiency • Lead, manage, mentor, hire, onboard, train, and evaluate Clinical Study Managers • Oversee CSM resources, workload, quality metrics, follow-ups, issue resolution, and stakeholder reporting • Facilitate CSM forums and support initiatives for improved clinical trial delivery • Promote quality, risk management, knowledge management, continuous improvement, innovation, and operational excellence • Review and support development of study start-up templates, drug labels, informed consent forms, and other applicable documents • Anticipate and address site issues, propose corrective and preventive actions, and contribute to clinical operations strategy • Conduct regular 1:1s, performance check-ins, reviews, and goal tracking • Manage functional service provider staff and coordinate with FSP leadership and line managers

🎯 Requirements

• Knowledge of clinical trial execution and ICH/GCP • Strong clinical operations knowledge • Organizational, project management, and leadership competencies • Effective prioritization of tasks • Strong written and verbal communication skills • Highly organized and diligent follow-through • Risk mitigation skills • Line management experience • Functional Service Provider model knowledge and/or experience • Mentoring and training experience • Proficiency in Microsoft Office, including Outlook, Word, Excel, PowerPoint, and Teams • Ability to ensure adherence to clinical trial processes, SOPs, local regulations, ICH guidelines, and GCP

🏖️ Benefits

• Occasional travel • Equal opportunity employment