Clinical Country Lead

In alignment with ICHGCP China GCP SOPs and local regulations the Clinical Country Lead (CCL) partners with GCO CRO and other functions to develop incountry operational plans aligned with Clinical Development Plan (global and China) and program level strategy the CCL is accountable for delivering the studies in China within timeline and with good quality.

The CCL leverages their phase indication and incountry operational expertise to independently oversee and take leadership for one or more clinical studies by establishing the incountry operational strategy and securing excellence in execution through the CRO partner.

• Develops and oversees implementation of China operational strategy for the successful delivery of clinical studies in China.
  • Develops China Operational strategy in line with CDP and China CDP.
  • Review and endorse countrylevel essential documents such as CSA Country ICF CTA and etc.
  • Leverages operational expertise and scientific assessment to evaluate country/site feasibility align with GCO on the Baseline country targe.
  • Effectively leads the study via 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.
• Oversees the delivery of studies by CROs ensuring quality execution in line with time forecast.
  • Acts as a member of the Study Management Team (SMT) collaborate crossfunctionally to operationalize the study in China.
  • CoChair the local operation call in partnership with the CRO local lead ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.
  • Manage study quality thorough Sponsor Oversight Visit (SOV) Support R&D Audit and CFDI inspection as needed.
  • Effectively engages KME in study activities from feasibility through closeout position Biogen as the company partner of choice for clinical trials.
  • Provide operational direction for activities of assigned CCA resources.
• Strives for effective consistent and efficient processes. 
  • Champions best practices and seeks opportunities to improve and streamline local processes to improve efficiency.
  • Promotes a rich and diverse knowledge base within China ClinOps contributing SME expertise where applicable.
  • Advocates for China ClinOps group and actively promotes interaction with other Biogen groups especially GCO.

Qualifications :

• Educational background in science (B.A. or B.S. preferred with an advanced degree being advantageous)
• Over 5 years of experience in project management specifically overseeing sponsor activities in an outsourced model with CROs/vendors.
• Extensive clinical project management experience from pharmaceutical companies.
• Proficiency in English.

Additional Information :

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

Where you are located in Mainland China and the Personal Information Protection Law (PIPL) applies for the purposes of conducting recruitment and HR management within China and having business communication and cooperation with the Overseas Recipient we will transfer your personal data (including name email address country phone number) to Biogen Inc (the Overseas Recipient) in the US (with the contact details and channel for exercising data subject rights at ) via Public Internet and Private Internet. The Overseas Recipient will collect store use and entrust information system service providers to process the Personal Data for the purposes of conducting unified HR management of the Biogen Group internal crossborder communication of the Biogen Group unified compliance management of the Biogen Group and providing information system technical services to the Biogen Group.