临床数据程序主管/经理

Essential Roles & Responsibilitie********

l Take responsibility an******** for data management or statisticalprogramming support for clinical trials. Serve as primary contact fordata management or statistical programming in the study team.Accountable for timely project delivery on high quality. Lea********study team meetings such as CRF review meet******** BDR meet********etc.

l Accountable for the implementation of DM/programming activities forstudies an********. Support rap******** for IND an******** submission.

l Be an expert in data management or statistical programming process.Make recommendation to the process improvement. Contribute to the SOPupdates.

l Develop strategy for the data management and/or the analysisan******** of clinical study data to support IND an******** submissionworking with clinical development project teams.

l Provide oversight to vendor to ensure the quality an******** of theDM/programming tasks. Actively oversee the project timeline an********closely with vendor to ensure all DM/programming relate******** areachieved. Monitor an******** vendor’s work. Provide technical guidanceto vendor DM******** in all relevant activities at study level.

l Accountable for the documentation maintenance an******** archiving forDM/programming function. Ensure inspection-readiness for theDM/programming deliverables in studies.

l Serves as a primary contact for DM/programming to support internalan******** audits. Communicate with regulatory authorities effectivelywith regar******** processes an******** at project level

Professional Experiences / Qualification********
l Bachelor/Master or above degree in a scientific discipline or healthrelate********. Master degree is preferred
l At least 4-6 Years of experience of data management or statisticalprogramming experiences in the pharmaceutical industry.
l Full understanding of data management an******** programming relevantregulatory guidelines.
l Experiences of supporting IND an******** submission is preferred.
l Goo******** of the CDISC standards.
l Specialty an******** in oncology study is preferred.
l Proficient in English an********, strong verbal an******** skills.

Location & Business Travel Requirement
Base******** Shanghai, China. Business Travel requirement subject toclinical planning.