RD-BioMarker Operations Manager-Shanghai

R&D - BioMarker Operations Manager - Shanghai-------------------------------------------------------------------------------------------------

This position is for a BioMarker Operations Manager/Outsourcng Managerwith expertise in biomarker an******** in Outsourcing an********Mon******** Project Operations in TMED (translational medicinean******** development). The main responsibilities include:



•Act as the project manager to support the externalization an******** ofbiomarkers an******** activities that are part of clinical programs
•Help support the team on the Budget pre******** management an********for a clear understanding of the Biomarker analysis an********’s impactto the project.
•Be the key point of contact of the updtaes for ALL biomarker activitiesfor a program whether they are manage******** or internally to allow theteam to be informe******** make data driven decisions
•Identify vendors for specific analys******** provide advice an********on scientifc an******** aspects of analysis where possible
•Interfacing with Central Lab Project Managers an******** management toensure the specifics to the logistics of sample support
•Support translational subteam of clinical projects with timelinesan******** of information
•Support the BioMarker an******** Bioanalysis lea******** logisticsan******** interfaces an********
•Interact closely with SANOFI TM Subteams teams responsible for theactivities that are externallycontracted
•Support the teams on importation or management of finalize******** foranalysis for clinical support
•Support the team on the oversight an******** of any PK or ADAacxtivities that have also been manage********
•Work collaboratively with the CROs, assure that all studies aremanage******** respect to t******** budget an******** deliverables
•Assure all aspects necessary for contracting studies are in place.This includes developing an******** a strong working relationship withPurchas******** Legal an******** support functions to provide RFQ(Requests for quote********), AEDs, Legal Contracts, etc..
•Monitor studies for their progress an******** relate******** thescientific integrity
•Collaborate with Q&C to establish an******** audits an******** thatselecte******** respect the quality assume******** SANOFI
•Interact with Regulatory Agencies an******** to support regulatory inspections