Roche Shanghai China
3 weeks ago
• Leads and manages a Clinical Operations function and team for the assigned affiliate and research and/or development organisation in the assigned division. Guides and ensures appropriate clinical operations input into relevant clinical development and/or medical plans to support affiliate and global clinical development and/or medical strategy execution.
• Oversees and guides affiliate clinical programs and associated clinical studies operations for the assigned therapeutic area(s), and assumes accountability for such, to ensure delivery of clinical operations activities to meet study plans outlined in clinical development and/or medical plans. Where applicable, ensures appropriate contract research organisation (CRO) and other vendor oversight. Ensures the assigned clinical operations team and vendor partners deliver on commitments and to agreed targets.
• Ensures study adherence to budget, ICH-GCP standards, Roche standard operating procedures and other operating... guidelines and regulatory requirements. Ensures assigned teams compliantly develop and cultivate productive relationships with external partners/stakeholders.
• Ensures that risk and quality plans are proactive and implemented for all studies and related activities for the assigned affiliate team.
• Drives study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvements. Selects, develops and evaluates employees to ensure the efficient operation of the function.
• PhD or Master Degree in Clinical Medicine or Clinical Laboratory education background.
• Clinical Research Qualification in accordance with Chinese laws and regulations, including but not limited to Good Clinical Practice (GCP) (GCP)
• At least 7 years working experience in medical clinical research in pharmaceutical, medical device or IVD companies.
• Excellent People Manager Experience
• Rich experience in Clinical research strategy implementation
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Bei Roche leisten 100,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.
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Sr Clinical Research Manager Shanghai jobs
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