Posted on: 2020-06-30

Job type: Permanent

Sector: Pharmaceutical and Healthcare

 
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CLINICAL AFFAIRS PERSPECTIVE
• The CSM was analyzing Chinese KOLs and different Universities/Hospitals in order to select most important partners to start clinical activities. The CSM role was to elaborate topics with those KOLs to start series of collaborations such as IITs and a reference center. Clinical support was focused on IITs.
• We expect to also run studies in China for registration purposes. First  we from HQ would prepare strategy and protocol, but for the conduct we need a local person with knowledge about clinical trials and who can find and assess necessary external partners (CROs) which we will need to have for a study appropriately run.
• The CSM would then be a local coordinator of all clinical activities connected with such study and act as a local study director. It is not clear what would be the load of such clinical studies over the coming years, therefore KOL liaison, education activities, IITs are important to have enough load in this CSM function.
• Support the recertification of all existing products in the Chinese market.
• Support the registration of Bio-Gide compressed and Bio-Guide shape as a local study coordinator reporting to China RA.
• Create a China-specific Clinical Science concept including projects, activities, milestones and priorities for success in the Chinese market.
• Create a detailed concept for the Centers of Excellence including an active collaboration with and coaching of these centers

CURRENT JOB DESCRIPTION (clinical support)
• Identify possible Investigators and Study Centers
• Discuss possible IIT projects with KOL
• Communicate the decision about the application to the KOL
• Fix the IIT contract according to our process with the KOL
• Act as the IRB national contact person
• Support study material logistics
• Provide HQ biannually with update reports
• Provide education about GCP
• Initiate and use of Material Transfer Agreements (MTA) to support KOL and strengthen relationship or build up relationship
• Be contact person for the Ethical Committee and provide study dependent management of the documentation for the Ethical Committee

Additional Clinical Affairs expectations for China
• Experience in clinical trial management
• Understanding of good clinical practice and local clinical regulations
• Worked with clinical monitors (CRAs), data managers, statisticians
• Natural science background and genuine interest in the dental field
• Experience in working with clinical experts (KOLs)

Clinical Affairs ‘nice to haves’:
• Experience in dental field, dentist education
• Existing dental network
• Experience in medical writing of protocols and reports
• Monitoring experience
• Existing CRO network
 

Contact

Sophie Fan
+ 86 10 8639 4819
Office 04-110, 4F, Tower B, Shimao Tower, 92A Jianguo Road, Chaoyang District, Beijing
100020 Beijing
Greater China

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Apply for Clinical Science Manager, China
Reference: GC821460

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