China Study Lead

Serves as the primary point of contact for all China study activities within a global or local clinical study. In alignment with ICH-GCP, China GCP, SOPs and local regulations, the China Study Lead (CSL) partners with QSDO, FSP resources, CRO and other functions to develop in-country operational plans aligned with Clinical Development Plan (global and China) and program level strategy, the CSL is accountable for delivering the studies in China on time,  within budget and with good quality.

Develops and oversees implementation of China operational strategy for the successful delivery of clinical studies in China. （40%）

• Develops China Operational strategy in line with CDP and China CDP.
• Review and endorse country-level essential documents such as CSA, Country ICF, CTA and etc.
• Leverages operational expertise and scientific assessment to evaluate country/site feasibility, align with QSDO on the Baseline country target.
• Effectively leads the study via managing FSP resources, providing oversight of the CRO, managing performance, quality, and timelines, including defining and delivering against a baseline plan.
• Ensures ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues.
• Takes Clinical Trial Lead role, chairs the SMT to drive the development of protocol, develops and oversees implementation of the study-level operational strategy for the successful delivery of China- alone studies lead by China R&D.

Drive the FSP resources and oversee CROs , ensuring the delivery of studies and quality execution in line with time forecast. （40%）

• If takes a CTL role, chairs the Study Management Team (SMT) in partnership with the CRO SMT Lead, ensures that all project plans (e.g. Monitoring Plan, Quality Plan, etc.) are in place for effective implementation of studies. Collaborates with CFP and procurement functions to ensure FMV is achieved, and budget oversight responsibilities are met. Maintains data accuracy, completeness and quality within study-related systems.
• Acts as an extended member of the Study Management Team (SMT), collaborate cross-functionally to operationalize and execute the study in China.
• Lead the FSP resources from trial Preparation, Conduct to Closeout.  Accountable for the operational management of the local component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.
• Co-Chair the local operation call in partnership with the CRO local lead, or FSP CML to ensure timely and effective risk mitigation plans.
• Manage study quality through Sponsor Oversight Visit (SOV), Support R&D Audit and CFDI inspection as needed.
• Effectively engages KME in study activities from feasibility through close-out, position Biogen as the company partner of choice for clinical trials.