Sr / Clinical Trial Manager (Mandarin)

Senior/Clinical Trial Manager (CTM) – Mandarin Key Areas of Responsibilities Manage all clinical aspects of a clinical trial and ensure trial execution in compliance with ICH/GCP guidelines/regulations and applicable SOPs Lead and collaborate effectively with cross‑functional teams to oversee the setup, execution, and management of complex clinical trials according to plan and in the highest quality standards Multi‑task in a fast‑paced environment with changing priorities and maintain accurate forecasts, clinical trial budgets, and timelines Assist in development and management of study budget and maintain it within financial goals; review and approve clinical invoices against approved budget Use operational and therapeutic expertise to optimize trial setup, implementation, and execution Proactively anticipate and identify study risks and issues, determine escalation pathways, and develop and implement solutions Conduct project risk analysis and develop risk mitigation strategies for a variety of complex problems to maintain study deliverables Provide technical expertise to oversee the development of clinical documents (protocol, informed consent form, CRF, monitoring plans, regulatory submission documents, clinical study report, investigator brochures, etc.) Provide clinical operations expertise and strategic leadership in the evaluation, selection, and management of CROs and other external vendors to ensure successful clinical trial implementation and execution of clinical trials and meet performance expectations Provide expertise in the identification, engagement, and selection of key trial centers/PIs, as well as develop relationships with investigators and site staff Ensure audit‑ready condition of clinical trial documentation and support inspection readiness activities Participate in the planning of quality assurance activities and coordinate resolution of audit findings, including management through resolution (CAPA) of any site or study‑level issues, deviations, etc. Actively provide direction and oversight and foster effective relationships with vendors, investigators, consultants, and colleagues Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function Manage and mentor clinical team members as needed Qualifications BA or BS in a scientific, life science, or health‑related discipline; advanced degree preferred CTM: Minimum of 5 to 7 years of experience in clinical research with 1–2 years managing trials in the biotech/pharma industry and/or prior CRO experience Sr. CTM: Minimum of 7+ years of experience in clinical research with at least 3–5 years managing trials in the biotech/pharma industry and/or prior CRO experience Fluent (verbal and written) in Mandarin Direct experience in a lead clinical operations role responsible for China‑based sites and enrollments Experience in setup, execution, and operational management of autoimmune trials—Sjogren's or Myasthenia Gravis preferred Excellent communication, writing, and presentation skills with strong problem‑solving ability and attention to detail Strong initiative and a can‑do attitude, excellent organizational skills, ability to prioritize deliverables/tasks to meet deadlines, proven effectiveness in a fast‑moving and growing biotech environment Solid working knowledge of Good Clinical Practices and ICH Guidelines and their application to the conduct of clinical trials Proficient in MS Office Suite, and understanding of Clinical Trial Management System, eTMF, and EDC systems Ability/willingness to travel both domestically and internationally, as required Senior/Clinical Trial Manager (CTM) – Consultant Key Areas of Responsibilities Manage all clinical aspects of a clinical trial and ensure trial execution in compliance with ICH/GCP guidelines/regulations and applicable SOPs Lead and collaborate effectively with cross‑functional teams to oversee the setup, execution, and management of complex clinical trials according to plan and in the highest quality standards Multi‑task in a fast‑paced environment with changing priorities and maintain accurate forecasts, clinical trial budgets, and timelines Assist in development and management of study budget and maintain it within financial goals; review and approve clinical invoices against approved budget Use operational and therapeutic expertise to optimize trial setup, implementation, and execution Proactively anticipate and identify study risks and issues, determine escalation pathways, and develop and implement solutions Conduct project risk analysis and develop risk mitigation strategies for a variety of complex problems to maintain study deliverables Provide technical expertise to oversee the development of clinical documents (protocol, informed consent form, CRF, monitoring plans, regulatory submission documents, clinical study report, investigator brochures, etc.) Provide clinical operations expertise and strategic leadership in the evaluation, selection, and management of CROs and other external vendors to ensure successful clinical trial implementation and execution of clinical trials and meet performance expectations Provide expertise in the identification, engagement, and selection of key trial centers/PIs, as well as develop relationships with investigators and site staff Ensure audit‑ready condition of clinical trial documentation and support inspection readiness activities Participate in the planning of quality assurance activities and coordinate resolution of audit findings, including management through resolution (CAPA) of any site or study‑level issues, deviations, etc. Actively provide direction and oversight and foster effective relationships with vendors, investigators, consultants, and colleagues Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function Manage and mentor clinical team members as needed Qualifications BA or BS in a scientific, life science, or health‑related discipline; advanced degree preferred CTM: Minimum of 5 to 7 years of experience in clinical research with 1–2 years managing trials in the biotech/pharma industry and/or prior CRO experience Sr. CTM: Minimum of 7+ years of experience in clinical research with at least 3‑5 years managing trials in the biotech/pharma industry and/or prior CRO experience Fluent (verbal and written) in Mandarin Direct experience in a lead clinical operations role responsible for China‑based sites and enrollments Experience in setup, execution, and operational management of autoimmune trials—Sjogren's or Myasthenia Gravis preferred Excellent communication, writing, and presentation skills with strong problem‑solving ability and attention to detail Strong initiative and a can‑do attitude, excellent organizational skills, ability to prioritize deliverables/tasks to meet deadlines, proven effectiveness in a fast‑moving and growing biotech environment Solid working knowledge of Good Clinical Practices and ICH Guidelines and their application to the conduct of clinical trials Proficient in MS Office Suite, and understanding of Clinical Trial Management System, eTMF, and EDC systems Ability/willingness to travel both domestically and internationally, as required #J-18808-Ljbffr