Job Description:
General Description:
Lead the delivery of study start-up, maintenance, and closeout activities, including initial and ongoing submissions, within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, local regulations, as well as BeiGene culture and Values. Whilst leading or contributing to process improvement and excellence initiatives. Support other SSUs as requiredEssential Functions of the job:
Contribute to Submission strategiesLead or Support the delivery of clinical start-up component of assigned studies with accountability for time, cost and quality for assigned activities, which include, but not limited to,Prepare and execute study submissions packages for IRB/IEC, Regulatory Authorities, Institutions, and any other submission requirements as neededClinical trial site contract and budget negotiation, if requiredSupport other functions as needed to ensure time...