職位描述
This is a Sr. CTA role in a TOP global pharma based in Shanghai. Candidate will be arranged to Evidence Generation team to assist the study documents management in both sponsored studies and ESRs.
Responsibilities and duties include, but are not limited to the following:
1.Responsibleforstudydocumentsfiling,trackingandarchivingandensuretheseactivitiesperformedincompliancewithGCP/SOPsandlocalregulation.
2.Responsibleforstudyadministrativesupportsincompliancewithaccordingcompanypolicyandlocalregulation.
3.ProvidinggeneraladministrativesupportstoCRAsandlinemanager.
4.Establishandmaintainsoundworkingrelationshipswithexternal(supplies,agency)andinternalcustomers(finance,IT)toproviderequiredsupportstoclinicaltrials.
5.Thisroleshouldunderstandcompany'scomplianceandSHEpolicy,andtomanagethedailyactivitytoalignwiththeseaccordingly.
6.ResponsibleforwellmanagingeTMFandpaperTMFofsponsored&Externallysponsoredstudy.(ifneeded)ChampionofeTMFsystem.
Qualifications:
1. Diploma or Bachelor Degree or above.
2. Majored on Medical/pharmacological/Nursing/Science is desirable.
3. Understand GCP, ICH GCP, HGR regulation. Good sense of this regulation.
4. 1~2 years experience as CTA/CPA/CTC is preferred.
5. Clinical Research experience on multinational pharma or CROs is a plus.
6. Fluent English in reading, writing and speaking.
7. Good communication skill, teamwork spirit, able to learn and adapt to IT system and scan equipment.
8.Good multi task management skill.
9. High motivation for the position and have clear picture of what this position will do.
