Sr Study Start Up Associate, Guangzhou

• As a member of staff, the employee is eJ(pected to embrace and contribute to our culture or process improvement with a focus on streamlining our processes adding value to our business and meeting cltent needs • ·rravel (approi<1mately 15%) dOmestJc and/or 1nternat1C>Oa! Anticipated activities may tnclude attendance at Bid Defences,Kick-Off,Investigator or study team meetings • Perform feasibility , siteidentificat10n ,site contract negouatron, and other study start up act1V1t1es. as assigned . • ·Provide country specific Study Start Up expertise to Study Stan Up Team Leads and project teams. • •Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies • 'Develop, finalize and revrew Master and Country Spec.fie Subject Information SheetSllnformeo Consent Forms (SISllCFa). • •Prepare. ·finaftze and relliew Master and Country Specific EU ClinJcal Trial Application Forms and corresponding data files in collaboration with other relevant departments (xm! file) (EU Only). • •Review and translate Drug labels • 'Performindependent quality revtew of submission packages • •Responsible for the translation and co-ordination of translat ons for documents required for submission. • •perform timely and accurate data entry of all relevant Study Stan Up activities into the appropriate cbnical trial management system • •Copy and routeincoming correspondence !nternaJ documentatiOo.etc ,as appropriate • ·Respons!ble for the timety follow-up f()( quenes made by EC/CA • •Responsible for the collection of cnt1cal documents required for IP Release • Responsfble for the dJSpa:cn,negotiation execution and tracking of contract with sites and other srtn. as appropriate. • •Responsible for the timely and accurate data entry of all relevant Study Start Up actrvmes into the appropnate clinical tnaJ management system 1n assigned countries • •Attend study team mttngs as required. including Kick-Off Meeting • Assemble and distnbute study materials to Clinical and Project teams.Including matenals to study sites andInvestigator Meetmgs (e g : investigator binders) and vendors.as appropriate.(US onJy) •·ResponS1ble for the collection and maintenance of the current Regulatory/Competent Authonty (CA) and Ethics Committee EC subm1sStOr1 information and similar information for oltler related Femi HRD2CNeision 2 OIEffectM! 28 ADt1I 2011 (Ref SOP HROZ) Pa90 2 ol 6 organizations,for the assigned countries and update relevantICON Information system. •·To be famUiar withICH GCP,reJevant country regulatioos/guidelmes and ICON SOPs • Competent in communication and tnfluenc1ng skills to ensure timely follow-up. issue resof\Jhon and report updates,as outlined 1n the communrcat1on and escalation plan with timely documentation • Perform regulatory document maintenance,amendments periodic updates and safety letters,where applicable • •Develop end matntain effective relationships with local,regional and country authoritres •·comply with all department requirements regarding information provision and status updating and reporting • To undertake and fulfill Study Start Up Team Lead role act1V1t1es as per the Study Start Up ream Lead scope defmftion 10 preparat on for future career progre$$!0n 10 Study Start Up Team Lead • To undertake other reasonably related duties as may be assigne